Goodman & Gilman's: Annual FDA Approvals

Morrison  C. Fresh from the biotech pipeline-2018. Nat Biotechnol. 2019;37(2):118–123.
[PubMed: 30718867] .

Crysvita^® (burosumab-twza) injection for subcutaneous use [product information]. Revised: 04/2018. Ultragenyx Pharmaceutical Inc.; Novato, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761068s000lbl.pdf (accessed Jan 1, 2019).

Gamifant^TM (emapalumab-lzsg) injection for intravenous use [product information]. Revised: 11/2018. Sobi Inc.; Waltham, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761107s000lbl.pdf (accessed Jan. 1, 2019).

Aimovig^TM (erenumab-aooe) injection for subcutaneous use [product information]. Revised: 5/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761077s000lbl.pdf (accessed Jan. 1, 2019).

Ajovy^TM (fremanezumab-vfrm) injection for subcutaneous use [product information]. Revised: 9/2018. Teva Pharmaceuticals USA, Inc.; North Wales, PA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf (accessed Jan. 1, 2019).

Emgality (galcanezumab-gnlm) injection for subcutaneous use [product information]. Revised: 9/2018. Eli Lilly and Company; Indianapolis, IN. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761063s000lbl.pdf (accessed Jan. 1, 2019).

Trogarzo^TM (ibalizumab-uiyk) injection for intravenous use [product information]. Revised: 05/2018. Theratechnologies Inc.; Montréal, Québec Canada. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf (accessed Mar. 2, 2019).

Takhzyro^TM (lanadelumab-flyo) injection for subcutaneous use [product information]. Revised: 11/2018. Dyax Corp.; Lexington, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s001lbl.pdf (accessed Jan. 1, 2019).

Poteligeo^® (mogamulizumab-kpkc) injection for intravenous use [product information]. Revised: 08/2018. Kyowa Kirin, Inc.; Bedminster Township, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf (accessed Jan. 1, 2019).

Oxervate^TM (cenegermin-bkbj) solution for topical ophthalmic use [product information]. Revised: 8/2018. Dompé U.S. Inc.; Boston, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf (accessed Mar. 2, 2019).

Andexxa^® (coagulation factor Xa (recombinant), inactivated-zhzo) lyophilized powder for solution and Intravenous Injection [product information]. Revised: 2018. Portola Pharmaceuticals, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM606687.pdf (accessed Mar. 2, 2019).

Palynziq (pegvaliase-pqpz) injection for subcutaneous use [product information]. Revised: 5/2018. BioMarin Pharmaceutical Inc.; Novato, CA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf (accessed Mar. 2, 2019).

Elzonris (tagraxofusp-erzs) injection for intravenous use [product information]. Revised: 12/2018. Stemline Therapeutics, Inc.; New York, NY. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf (accessed Mar. 2, 2019).

FDA-Approved Biosimilar Products [webpage]. Last Updated: 12/14/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm (accessed Jan. 1, 2019).

Biosimilar and Interchangeable Products [webpage]. Last Updated: 10/23/2017. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm (accessed Feb. 19, 2018).

Center for Drug Evaluation and Research List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date [webpage]. Last Updated: 2/6/2019. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf (accessed Feb. 22, 2019).

Lumoxiti^TM (moxetumomab pasudotox-tdfk) injection for intravenous use [product information]. Revised: 9/2018. AstraZeneca Pharmaceuticals LP; Wilmington, DE. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf (accessed Jan. 1, 2019).

Libtayo^® (cemiplimab-rwlc) injection for intravenous use [product information]. Revised: 09/2018. Regeneron Pharmaceuticals, Inc.; Tarrytown, NY. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf (accessed Jan. 1, 2019).

Ultomiris^TM (ravulizumab-cwvz) injection for intravenous use [product information]. Revised: 12/2018. Alexion Pharm; Boston, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf (accessed Jan. 1, 2019).

Ilumya^TM (tildrakizumab-asmn) injection for subcutaneous use [product information]. Revised: 03/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf (accessed Jan. 1, 2019).

Biological License Application Approvals [webpage]. Last Updated: 01/31/2019. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm596371.htm (accessed Mar. 2, 2019).

Asparlas^TM (calaspargase pegol-mknl) injection, for intravenous use [product information]. Revised: 12/2018. Servier Pharmaceuticals LLC. Boston, MA. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf (accessed Mar. 2, 2019).

Revcovi (elapegademase-lvlr) injection for intramuscular use [product information]. Revised: 10/2018. Leadiant Biosciences, Inc.; Gaithersburg, MD). Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761092s000lbl.pdf (accessed Mar. 2, 2019).

Vaxelis^TM (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Suspension for Intramuscular Injection [product information]. Revised: 12/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM629109.pdf (accessed Mar. 2, 2019).

CY 2018 CDER Breakthrough Therapy Calendar Year Approvals: Data as of December 31, 2018 [webpage]. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/ndaandblaapprovalreports/ucm494010.pdf (accessed Feb. 21, 2019).

Gardasil^® (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for Intramuscular injection [product information. Revised: 10/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf (accessed Mar. 2, 2019).

Gardasil 9 [webpage]. Last Updated: 10/10/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm426445.htm (accessed Mar. 2, 2019).

FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia [FDA News Release]. April 17, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604810.htm (accessed Jan. 1, 2019).

Drug Trials Snapshot: CRYSVITA [webpage] Page Last Updated: 05/01/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm605956.htm (accessed Jan. 1, 2019).

FDA approves first drug for neurotrophic keratitis, a rare eye disease [FDA News Release]. August 22, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm618047.htm (accessed Mar. 2, 2019).

Drug Trials Snapshot: Gamifant [webpage]. Last Updated: 12/07/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm627806.htm (accessed Jan. 1, 2019).

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease [FDA News Release]. November 20, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626263.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves emapalumab for hemophagocytic lymphohistiocytosis [webpage]. Last Updated: Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626280.htm (accessed Jan. 1, 2019).

Drug Trials Snapshots: Aimovig [webpage]. Last Updated: 06/14/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm610434.htm (accessed Jan. 1, 2019).

FDA approves novel preventive treatment for migraine [FDA News Release]. May 17, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm (accessed Jan. 1, 2019).

Drug Trials Snapshot: Ajovy [webpage]. Last Updated: 10/15/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm623050.htm (accessed Jan. 1, 2019).

FDA approves new HIV treatment for patients who have limited treatment options [FDA News Release]. March 6, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm (accessed Jan. 6, 2019).

Drug Trials Snapshots: Trogarzo [webpage]. Last Updated: 03/20/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm601383.htm (accessed Jan. 1, 2019).

FDA approves new treatment for rare hereditary disease [FDA News Release]. August 23, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm618261.htm (accessed Jan. 1, 2019).

Drug Trials Snapshots: Takhzyro [webpage]. Last Updated: 09/06/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ucm619361.htm (accessed Jan. 1, 2019).

FDA approves treatment for two rare types of non-Hodgkin lymphoma [FDA News Release]. August 8, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616176.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves mogamulizumab-kpkc for mycosis fungoides or Sézary syndrome [webpage]. Last Updated: 08/08/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm616180.htm (accessed Jan. 3, 2019).

Drug Trials Snapshot: Poteligeo [webpage]. Last Updated: 08/22/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm617675.htm (accessed Jan. 1, 2019).

FDA approves a new treatment for PKU, a rare and serious genetic disease [FDA News Release]. May 24, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608835.htm (accessed Jan. 1, 2019).

Drug Trials Snapshot: Palynziq [webpage]. Last Updated: 06/21/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm611328.htm (accessed Jan. 1, 2019).

FDA approves new treatment for adult patients with rare, life-threatening blood disease [FDA News Release]. December 21, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629022.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm [webpage]. Last Updated: 12/21/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm629090.htm (accessed Jan. 3, 2019).

Russell  FA, King  R, Smillie  SJ,  et al. Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev. 2014;94(4):1099–1142.
[PubMed: 25287861] ; PubMed Central PMCID: PMC4187032.

American Headache Society. The American Headache Society Position Statement On Integrating New Migraine Treatments Into Clinical Practice. Headache. 2019;59(1):1–18.
[PubMed: 30536394] .

Jo  M, Jung  ST. Engineering therapeutic antibodies targeting G-protein-coupled receptors. Exp Mol Med. 2016;48:e207.
[PubMed: 26846450] ; PubMed Central PMCID: PMC4892866.

Diener  HC. CGRP antibodies for migraine prevention—new kids on the block. Nat Rev Neurol. 2019;15(3):129–130.
[PubMed: 30710130] .

Dolgin  E. First GPCR-directed antibody passes approval milestone. Nat Rev Drug Discov. 2018;17(7):457–459.
[PubMed: 29950713] .

Noonan  D. New Nerve Drugs May Finally Prevent Migraine Headaches. December 1, 2015. Available from: Scientific American. www.scientificamerican.com/article/new-nerve-drugs-may-finally-prevent-migraine-headaches/ (accessed Mar. 2, 2019).

Edvinsson  L, Haanes  KA, Warfvinge  K,  et al. CGRP as the target of new migraine therapies—successful translation from bench to clinic. Nat Rev Neurol. 2018;14(6):338–350. Review.
[PubMed: 29691490] .

Majima  M, Ito  Y, Hosono  K,  et al. CGRP/CGRP Receptor antibodies: Potential adverse effects due to blockade of neovascularization? Trends Pharmacol Sci. 2019;40(1):11–21.
[PubMed: 30502971] .

Kee  Z, Kodji  X, Brain  SD. The role of calcitonin gene related peptide (CGRP) in neurogenic vasodilation and its cardioprotective effects. Front Physiol. 2018;9:1249.
[PubMed: 30283343] ; PubMed Central PMCID: PMC6156372.

Bigal  ME, Rapoport  AM, Silberstein  SD,  et al. From LBR-101 to fremanezumab for migraine. CNS Drugs. 2018;32(11):1025–1037.
[PubMed: 30311143] .

Bohm  PE, Stancampiano  FF, Rozen  TD. Migraine headache: Updates and future developments. Mayo Clin Proc. 2018;93(11):1648–1653.
[PubMed: 30392545] .

Sparrow  AM, Searles  JW. The market for migraine drugs. Nat Rev Drug Disc. Available from: NatureResearch. http://www.nature.com/articles/d41573-018-00014-3 (accessed Mar. 2, 2019).

Teva Announces U.S. Approval of AJOVY^TM (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults [Press Release]. September 14, 2018. https://ir.tevapharm.com/investors/press-releases/press-release-details/2018/Teva-Announces-US-Approval-of-AJOVY-fremanezumab-vfrm-Injection-the-First-and-Only-Anti-CGRP-Treatment-with-Both-Quarterly-and-Monthly-Dosing-for-the-Preventive-Treatment-of-Mig (accessed Mar. 2, 2019).

Dolgin  E. Migraine drug race turns its final corner, FDA decisions in sight. Nat Biotechnol. 2018;36(3):207–208.
[PubMed: 29509726] .

Babina  IS, Turner  NC. Advances and challenges in targeting FGFR signalling in cancer. Nat Rev Cancer. 2017;17(5):318–332.
[PubMed: 28303906] .

Vervloet  M. Renal and extrarenal effects of fibroblast growth factor 23. Nat Rev Nephrol. 2019;15(2):109–120.
[PubMed: 30514976] .

Kuro-O  M. The Klotho proteins in health and disease. Nat Rev Nephrol. 2019;15(1):27–44.
[PubMed: 30455427] .

Razzaque  MS. The FGF23-Klotho axis: endocrine regulation of phosphate homeostasis. Nat Rev Endocrinol. 2009;5(11):611–619.
[PubMed: 19844248] ; PubMed Central PMCID: PMC3107967.

Highly specialised technologies guidance [HST8]: Burosumab for treating X-linked hypophosphataemia in children and young people. October 10, 2018. Available from: National Institute for Health Care Excellence (UK). www.nice.org.uk/guidance/hst8/chapter/7-Evaluation-committee-members-and-NICE-project-team (accessed Mar. 2, 2019).

Genetics Home Reference: PHEX gene (phosphate regulating endopeptidase homolog X-linked) [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/gene/PHEX - synonyms (accessed Mar. 2, 2019).

Committee for Medicinal Products for Human Use (CHMP) Assessment Report: Crysvita. December 14, 2017. EMA/148319/2018. Procedure No. EMEA/H/C/004275/0000. Available from: European Medicines Agency; London, England. http://www.ema.europa.eu/documents/assessment-report/crysvita-epar-public-assessment-report_en.pdf (accessed Mar. 2, 2019).

Center for Drug Evaluation and Research. FDA MultiDisciplinary Review BLA 761068 (burosumab twza). Application Number: 761068Orig1s000. Digitally signed on January 17, 2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000MultidisciplineR.pdf (accessed Mar. 2, 2019).

Kinoshita  Y, Fukumoto  S. X-linked hypophosphatemia and FGF23-related hypophosphatemic diseases: Prospect for new treatment. Endocr Rev. 2018;39(3):274–291.
[PubMed: 29381780] .

Minisola  S, Peacock  M, Fukumoto  S,  et al. Tumour-induced osteomalacia. Nat Rev Dis Primers. 2017;3:17044.
[PubMed: 28703220] .

DataFacts [electronic notification tool for Medi-Span]. Update for Week of 04/22/18 to 04/28/18. Available from: Wolters Kluwer Clinical Drug Information. https://wds.medispan.com/DataFacts/DataFactsDocumentsDownload.aspx?file=%5C120%20United%20States%5C110%20US%20DataFacts%5C099%202018%5CUS_DataFacts_04-28-2018.htm (accessed Feb. 14, 2019).

Versura  P, Giannaccare  G, Pellegrini  M,  et al. Neurotrophic keratitis: Current challenges and future prospects. Eye Brain. 2018;10:37–45.
[PubMed: 29988739] ; PubMed Central PMCID: PMC6029608.

Committee for Medicinal Products for Human Use (CHMP) Assessment report: Oxervate. May 18, 2017. EMA/351805/2017. Procedure No. EMEA/H/C/004209/0000. Available from: European Medicines Agency; London, England. www.ema.europa.eu/documents/assessment-report/oxervate-epar-public-assessment-report_en.pdf (accessed Mar. 2, 2019).

ClinicalTrials.gov. Identifier NCT03085290, Allogeneic Versus Autologous Serum Eye Drops (AVAnS). Available from: U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT03085290 (accessed Mar. 2, 2019).

Clinical Guidelines: Serum Eye Drops for the Treatment of Severe Ocular Surface Disease. September 2017. Available from: The Royal College of Ophthalmologists. www.rcophth.ac.uk/wp-content/uploads/2017/11/Serum-Eye-Drops-Guideline.pdf (accessed Feb. 14, 2019).

Technology appraisal guidance [TA532]: Cenegermin for treating neurotrophic keratitis. Published: July 18, 2018. Available from: National Institute for Health Care Excellence (UK). http://www.nice.org.uk/guidance/ta532 (accessed Mar. 2, 2019).

Sacchetti  M, Bruscolini  A, Lambiase  A. Cenegermin for the treatment of neurotrophic keratitis. Drugs Today (Barc). 2017;53(11):585–595.
[PubMed: 29451275] .

DataFacts [electronic notification tool for Medi-Span]. Update for Week of 11/18/18 to 11/24/18. Available from: Wolters Kluwer Clinical Drug Information. https://wds.medispan.com/DataFacts/DataFactsDocumentsDownload.aspx?file=%5C120%20United%20States%5C110%20US%20DataFacts%5C099%202018%5CUS_DataFacts_11-24-2018.htm (accessed Feb. 14, 2019).

Denby  A. London Medicines Evaluation Network Review: A summary of new antidotes to New Oral Anticoagulants (NOAC’s) and antidotes to NOAC’s currently in development, which could impact NOAC use in the future (Version Number: 1). February 2016. Available from: National Health Service Specialist Pharmacy Service (UK). http://www.sps.nhs.uk/wp-content/uploads/2016/02/LMEN_NOAC_antidotes_FINAL_FEB_2016.pdf (accessed Mar. 2, 2019).

Tornkvist  M, Smith  JG, Labaf  A. Current evidence of oral anticoagulant reversal: A systematic review. Thromb Res. 2018;162:22–31.
[PubMed: 29258056] .

Andexxa—an antidote for apixaban and rivaroxaban. Med Lett Drugs Ther. 2018;60(1549):99-101. Corrected and republished in: JAMA. 2018;320(4):399–400.
[PubMed: 29913471] .

Andexxa—an antidote for apixaban and rivaroxaban. JAMA. 2018;320(4):399–400.
[PubMed: 30043058] .

DataFacts [electronic notification tool for Medi-Span]. Update for Week of 05/13/18 to 05/19/18. Available from: Wolters Kluwer Clinical Drug Information. https://wds.medispan.com/DataFacts/DataFactsDocumentsDownload.aspx?file=%5C120 United States%5C110 US DataFacts%5C099 2018%5CUS_DataFacts_05-19-2018.htm (accessed Feb. 14, 2019).

Canna  SW, Behrens  EM. Making sense of the cytokine storm: a conceptual framework for understanding, diagnosing, and treating hemophagocytic syndromes. Pediatr Clin North Am. 2012;59(2):329–344.
[PubMed: 22560573] ; PubMed Central PMCID: PMC3368378.

Esteban  YM, de Jong  JLO, Tesher  MS. An overview of hemophagocytic lymphohistiocytosis. Pediatr Ann. 2017;46(8):e309–e313.
[PubMed: 28806468] .

Zhang  K, Filipovich  AH, Johnson  J,  et al. Hemophagocytic Lymphohistiocytosis, Familial. 2006 Mar 22 [Updated 2013 Jan 17]. In: Adam  MP, Ardinger  HH, Pagon  RA,  et al., editors. GeneReviews^® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2019. Available from: http://www.ncbi.nlm.nih.gov/books/NBK1444/ (accessed Mar. 2, 2019).

Genetics Home Reference: Familial hemophagocytic lymphohistiocytosis [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/condition/familial-hemophagocytic-lymphohistiocytosis (accessed Mar. 2, 2019).

DataFacts [electronic notification tool for Medi-Span]. Update for Week of 12/23/18 to 12/29/18. Available from: Wolters Kluwer Clinical Drug Information. https://wds.medispan.com/DataFacts/DataFactsDocumentsDownload.aspx?file=%5C120 United States%5C110 US DataFacts%5C099 2018%5CUS_DataFacts_12-29-2018.htm (accessed Feb. 14, 2019).

Iacob  SA, Iacob  DG. Ibalizumab targeting CD4 receptors, an emerging molecule in HIV therapy. Front Microbiol. 2017;8:2323.
[PubMed: 29230203] ; PubMed Central PMCID: PMC5711820.

Deng  B. First Chinese-made biologics slated for human trials in the West. Nat Med. 2014;20(6):562.
[PubMed: 24901550] .

HIV Replication Cycle Infographic [webpage]. Available from: National Institute of Allergy and Infectious Diseases (US). www.niaid.nih.gov/diseases-conditions/hiv-replication-cycle (accessed Mar. 2, 2019).

New drug for multidrug-resistant HIV [news]. Nature Biotechnology. 2018/04/05/online: 36: 291. Available from: Nature Publishing Group. https://doi.org/10.1038/nbt0418-291b (accessed Mar. 2, 2019).

Levin,  J. NATAP Glasgow HIV Conference Report: Cohen Z. Outcomes of patients not achieving primary endpoint from an ibalizumab phase 3 trial. November 1, 2018. NATAP Glasgow HIV Conference. October 27 – 31, 2018. Glasgow, UK. Available from National AIDS Treatment Advocacy Project. www.natap.org/2018/GLASGOW/GLASGOW_59.htm (accessed Mar. 2, 2019).

Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV [webpage]. Last Updated: October 25, 2018. Available from: U.S. Department of Health and Human Services. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/37/whats-new-in-the-guidelines- (accessed Mar. 2, 2019).

Trogarzo^TM (ibalizumab-uiyk)—New orphan drug approval. March 6, 2018. Available from: OptumRx Clinical Services Department. https://professionals.optumrx.com/content/dam/optum3/professional-optumrx/news/rxnews/drug-approvals/drugapprovals_trogarzo_2018-0307.pdf (accessed Mar. 2, 2019).

Single Technology Appraisal: Appendix B—Lanadelumab for the long-term prevention of angioedema attacks in hereditary angioedema types I and II. Published: July 18, 2018. Available from: National Institute for Health Care Excellence (UK). October 2018. www.nice.org.uk/guidance/gid-ta10333/documents/final-scope (accessed Feb. 9, 2019).

Banerji  A, Busse  P, Shennak  M,  et al. Inhibiting plasma kallikrein for hereditary angioedema prophylaxis. N Engl J Med. 2017;376(8):717–728.
[PubMed: 28225674] .

Bork  K. A decade of change: recent developments in pharmacotherapy of hereditary angioedema (HAE). Clin Rev Allergy Immunol. 2016;51(2):183–192.
[PubMed: 27207174] .

Genetics Home Reference: Hereditary Angioedema [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/condition/hereditary-angioedema (accessed Mar. 2, 2019).

DataFacts [electronic notification tool for Medi-Span]. Update for Week of 08/26/18 to 09/01/18. Available from: Wolters Kluwer Clinical Drug Information. https://wds.medispan.com/DataFacts/DataFactsDocumentsDownload.aspx?file=%5C120 United States%5C110 US DataFacts%5C099 2018%5CUS_DataFacts_09-01-2018.htm (accessed Feb. 14, 2019).

Zhang  LL, Wei  JY, Wang  L,  et al. Human T-cell lymphotropic virus type 1 and its oncogenesis. Acta Pharmacol Sin. 2017;38(8):1093–1103.
[PubMed: 28392570] ; PubMed Central PMCID: PMC5547553.

Garber  K. No added sugar: antibody makers find an upside to 'no fucose'. Nat Biotechnol. 2018;36(11):1025–1027.
[PubMed: 30412203] .

Dolgin  E. First GPCR-directed antibody passes approval milestone. Nat Rev Drug Discov. 2018;17(7):457–459.
[PubMed: 29950713] .

Technologies: Potelligent^® [webpage]. Available from: BioWa Inc. http://www.kyowa-kirin.com/biowa/out-licensing/technologies/index.html (accessed Feb. 11, 2019).

Pereira  NA, Chan  KF, Lin  PC,  et al. The "less-is-more" in therapeutic antibodies: Afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity. MAbs. 2018;10(5):693–711.
[PubMed: 29733746] ; PubMed Central PMCID: PMC6150623.

Welborn  M, Duvic  M. Antibody-based therapies for cutaneous t-cell lymphoma. Am J Clin Dermatol. 2019;20(1):115–122.
[PubMed: 30430444] .

Beck  A. Biosimilar, biobetter and next generation therapeutic antibodies. MAbs. 2011;3(2):107–110.
[PubMed: 21285536] ; PubMed Central PMCID: PMC3092613.

Beck  A, Reichert  JM. Marketing approval of mogamulizumab: a triumph for glyco-engineering. MAbs. 2012;4(4):419–425.
[PubMed: 22699226] ; PubMed Central PMCID: PMC3499336.

Wilcox  RA. Mogamulizumab: 2 birds, 1 stone. Blood. 2015;125(12):1847–1848.
[PubMed: 25792728] .

Togashi  Y, Shitara  K, Nishikawa  H. Regulatory T cells in cancer immunosuppression—implications for anticancer therapy. Nat Rev Clin Oncol. 2019;16(6):356–371.
[PubMed: 30705439] .

Sugata  K, Yasunaga  J, Miura  M,  et al. Enhancement of anti-STLV-1/HTLV-1 immune responses through multimodal effects of anti-CCR4 antibody. Sci Rep. 2016;6:27150.
[PubMed: 27250643] ; PubMed Central PMCID: PMC4890010.

Mullard  A. FDA approves second GPCR-targeted antibody. Nat Rev Drug Discov. 2018;17(9):613.
[PubMed: 30160256] .

Genetics Home Reference: Mycosis Fungoides [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/condition/mycosis-fungoides (accessed Mar. 3, 2019).

Genetics Home Reference: Sézary Syndrome [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/condition/sezary-syndrome (accessed Mar. 3, 2019).

Poteligeo Prices, Coupons & Patient Assistance Programs [webpage]. Last Updated: March 3, 2019. Available from: Drugs.com. http://www.drugs.com/price-guide/poteligeo (accessed Mar. 3, 2019).

Levy  HL, Sarkissian  CN, Scriver  CR. Phenylalanine ammonia lyase (PAL): From discovery to enzyme substitution therapy for phenylketonuria. Mol Genet Metab. 2018;124(4):223–229.
[PubMed: 29941359] .

Genetics Home Reference: Phenylketonuria [webpage]. February 26, 2019. Available from: U.S. National Library of Medicine. https://ghr.nlm.nih.gov/condition/phenylketonuria (accessed Mar. 3, 2019).

Vockley  J, Andersson  HC, Antshel  KM,  et al. Phenylalanine hydroxylase deficiency: diagnosis and management guideline. Genet Med. 2014;16(2):188–200. Erratum in: Genet Med. 2014;16(4):356.
[PubMed: 24385074] .

Longo  N, Dimmock  D, Levy  H,  et al. Evidence- and consensus-based recommendations for the use of pegvaliase in adults with phenylketonuria. Genet Med. 2018 [Epub ahead of print].
[PubMed: 30546086] .

Approved Risk Evaluation and Mitigation Strategies (REMS): Palynziq (pegvaliase-pqpz) BLA #761079 [webpage]. REMS last update: 05/24/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. http://www.accessdata.fda.gov/Scripts/Cder/Rems/index.cfm?event=IndvRemsDetails.page&REMS=381 (accessed Mar. 3, 2019).

Fliesler  N. Boston Childrens Hospital Science and Clinical Innovation blog: Phenylketonuria without the ‘phe’: Enzyme therapy offers chance at a better life. June 27, 2018. https://vector.childrenshospital.org/2018/06/phenylketonuria-pegvaliase/ (accessed Mar. 3, 2019).

National Institute for Health Research Innovation Observatory Evidence Briefing [document]: Tagraxofusp for blastic plasmacytoid dendritic cell neoplasm. Sep 4, 2018. Available from: National Health Service (UK). http://www.io.nihr.ac.uk/wp-content/uploads/2018/09/12136-Tagraxofusp-for-BPDCN-V1.0-SEP2018-NON-CONF.pdf (accessed Feb. 11, 2019).

Frankel  AE, Woo  JH, Ahn  C,  et al. Activity of SL-401, a targeted therapy directed to interleukin-3 receptor, in blastic plasmacytoid dendritic cell neoplasm patients. Blood. 2014;124(3):385–392.
[PubMed: 24859366] ; PubMed Central PMCID: PMC4260361.

NCBI Gene [Internet]: IL3RA interleukin 3 receptor subunit alpha [Homo sapiens (human)]. Gene ID: 3563. Updated Feb. 13, 2019. Available from: National Center for Biotechnology Information, U.S. National Library of Medicine. www.ncbi.nlm.nih.gov/gene/3563 (accessed Mar. 3, 2019).

Hamilton  JA, Cook  AD, Tak  PP. Anti-colony-stimulating factor therapies for inflammatory and autoimmune diseases. Nat Rev Drug Discov. 2016;16(1):53–70.
[PubMed: 28031576] .

Stephansky  J, Togami  k, Ghandi  M  et al. Resistance to SL-401 in AML and BPDCN is associated with loss of the diphthamide synthesis pathway enzyme DPH1 and is reversible by azacitidine [abstract]. Blood. 2017;130(6):797.

Ontak^® (denileukin diftitox) injection for intravenous infusion [product information]. Revised: February 2019. Eisai Inc.; Woodcliff Lake, NJ [product information]. Revised: http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103767s5143lbl.pdf (accessed Mar. 3, 2019).

Pardanani  A, Lasho  T, Chen  D,  et al. Aberrant expression of CD123 (interleukin-3 receptor-α) on neoplastic mast cells. Leukemia. 2015;29(7):1605–1608.
[PubMed: 25640886] .

Kaushansky  k, Kipps  T. Chapter 41. Hematopoietic Agents: Growth Factors, Minerals, and Vitamins > Growth Factor Physiology. In: Brunton  LL, Hilal-Dandan  R, Knollmann  BC. eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 13e New York, NY: McGraw-Hill; 2018. Available from McGraw Hill Education. https://accessmedicine-mhmedical-com/content.aspx?sectionid=172481461&bookid=2189&jumpsectionID=194550389&Resultclick=2 (accessed Mar. 3, 2019).

Stemline Therapeutics Announces Presentation of Elzonris^TM (tagraxofusp; SL-401) Preclinical Data in Systemic Sclerosis, an Autoimmune Disorder, at EULAR Congress [Information for Investors]. June 15, 2018. Available from: Stemline Therapeutics, Inc. https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-announces-presentation-elzonristm (accessed Feb. 12, 2019).

Alkharabsheh  O, Frankel  AE. Clinical activity and tolerability of SL-401 (tagraxofusp): Recombinant diphtheria toxin and interleukin-3 in hematologic malignancies. Biomedicines. 2019;7(1):E6.
[PubMed: 30621282] .

Blastic Plasmacytoid Dendritic Cell Neoplasm [webpage]. Available from: The Leukemia & Lymphoma Society. http://www.lls.org/leukemia/blastic-plasmacytoid-dendritic-cell-neoplasm (accessed Feb. 12, 2019).

Facchetti  F, Cigognetti  M, Fisogni  S,  et al. Neoplasms derived from plasmacytoid dendritic cells. Mod Pathol. 2016;29(2):98–111.
[PubMed: 26743477] .

Nigam  P. Stemline's Elzonris Launch On Schedule, HC Wainwright Says In Bullish Initiation. Dec 26, 2018. Available from Benzinga. www.benzinga.com/analyst-ratings/analyst-color/18/12/12899661/stemlines-elzonris-launch-on-schedule-hc-wainwright-say (accessed Mar. 3, 2019).

Swiecki  M, Colonna  M. The multifaceted biology of plasmacytoid dendritic cells. Nat Rev Immunol. 2015;15(8):471–485.
[PubMed: 26160613] ; PubMed Central PMCID: PMC4808588.

Kaplon  H, Reichert  JM. Antibodies to watch in 2019. MAbs. 2019;11(2):219–238.
[PubMed: 30516432] ; PubMed Central PMCID: PMC6380461.

Adalimumab-adaz injection for subcutaneous use (HYRIMOZ) [product information]. Sandoz Inc.; Princeton, NJ. Revised: 10/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761071lbl.pd (accessed Jan. 1, 2019).

Humira^® (adalimumab) injection, for subcutaneous use [product information]. Revised: 12/2018. AbbVie Inc.; North Chicago, IL. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf (accessed Feb. 25, 2019).

Albuminex^® 5% (human albumin) solution for injection [product information]. Revised: 8/2018. Bio Products Laboratory USA Inc.; Durham, NC. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM611356.pdf (accessed Mar. 3, 2019).

Jivi^® [antihemophilic factor (recombinant), PEGylated-aucl] [product information]. Revised: 8/2018. Bayer HealthCare LLC; Whippany, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM618979.pdf (accessed Mar. 3, 2019).

Asparlas^TM (calaspargase pegol-mknl) injection for intravenous use [product information]. Revised: 12/2018 Servier Pharmaceuticals LLC.; Boston, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf (accessed Mar. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves longer-acting calaspargase pegol-mknl for ALL [webpage]. Last Updated: 12/26/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628980.htm (accessed Jan. 3, 2019).

FDA approves first treatment for advanced form of the second most common skin cancer [FDA News Release]. September 28, 2018. Last Updated: 12/26/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622044.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma [webpage]. Last Updated: 11/30/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm622251.htm (accessed Jan. 3, 2019).

Drug Trials Snapshot: Libtayo [website]. Last Updated: 10/11/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm623057.htm (accessed Jan. 1, 2019).

Drug Trial Snapshot: Revcovi [website]. Last Updated: 11/02/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm624818.htm (accessed Jan. 3, 2019).

Retacrit^TM (epoetin alfa-epbx) injection for intravenous or subcutaneous use [product information]. Revised: 5/2018. Pfizer Labs; New York, NY. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf (accessed Jan. 1, 2019).

FDA approves first epoetin alfa biosimilar for the treatment of anemia [FDA News Release]. May 15, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607703.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves Retacrit as a biosimilar to Epogen/Procrit [webpage]. Last Updated: 05/15/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm607723.htm (accessed Jan. 3, 2019).

Epogen^® (epoetin alfa) injection, for intravenous or subcutaneous use [product information]. Revised: 7/2018. Janssen Products, LP.; Horsham, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103234s5369lbl.pdf (accessed Jan. 3, 2019).

Nivestym^TM (filgrastim-aafi) injection for subcutaneous or intravenous use [product information]. Revised: 7/2018. Hospira, Inc.; Lake Forest, IL. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf (accessed Jan. 1, 2019).

Neupogen^® (filgrastim) injection for subcutaneous or intravenous use [product information]. Revised: 6/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103353s5194lbl.pdf (accessed Jan. 3, 2019).

Panzyga, (immune globulin intravenous, human - ifas) 10% Liquid Preparation [product information]. Revised: 8/2018. Octapharma USA, Inc.; Hoboken, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM615706.pdf (accessed Jan. 3, 2019).

FDA approves new kind of treatment for hairy cell leukemia [FDA News Release]. September 13, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620448.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves moxetumomab pasudotox-tdfk for hairy cell leukemia [webpage]. Last Updated: 11/29/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm620473.htm (accessed Jan. 3, 2019).

Drug Trials Snapshot: Lumoxiti [webpage]. Last Updated: 09/25/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm621522.htm (accessed Jan. 1, 2019).

Udenyca^TM (pegfilgrastim-cbqv) injection for subcutaneous use [product information]. Revised: 11/2018. Coherus BioSciences, Inc.; Redwood City, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761039s000lbl.pdf (accessed Jan. 1, 2019).

Fulphila (pegfilgrastim-jmdb) injection for subcutaneous use [product information]. Revised: 6/2018. Mylan GmbH; Zurich, Switzerland. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761075s000lbl.pdf (accessed Jan. 1, 2019).

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment [FDA News Release]. June 4, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves first biosimilar to Neulasta to decrease the risk of infection during cancer treatment [webpage]. Last Updated: 06/05/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm609823.htm (accessed Jan. 3, 2019).

Neulasta (pegfilgrastim) injection for subcutaneous use [product information]. Revised: 11/2015. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf (accessed Mar. 3, 2019).

Ultomiris^TM (ravulizumab-cwvz) injection for intravenous use [product information]. Revised: 12/2018. Alexion Pharmaceuticals, Inc.; Cambridge, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761108s000lbl.pdf (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves ravulizumab-cwvz for paroxysmal nocturnal hemoglobinuria [webpage]. Last Updated: 12/26/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm629088.htm (accessed Jan. 3, 2019).

Truxima^® (rituximab-abbs) injection for intravenous use [product information]. Revised: 11/2018. Teva Pharmaceuticals USA, Inc; North Wales, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications:FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm627035.htm (accessed Jan. 3, 2019).

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma [FDA News Release]. November 28, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627009.htm (accessed Jan. 4, 2019).

Rituxan^® (rituximab) injection for intravenous use [product information]. Revised: 01/2019. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5454lbl.pdf (accessed Mar. 3, 2019).

Drug Trials Snapshots: Ilumya [webpage]. Last Updated: 04/06/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ucm603480.htm (accessed Jan. 1, 2019).

Herzuma^® (trastuzumab-pkrb) for injection for intravenous use [product information]. Revised: 12/2018. Teva Pharmaceuticals USA, Inc.; North Wales, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf (accessed Jan. 1, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves Herzuma as a biosimilar to Herceptin [webpage]. Last Updated: 12/18/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628724.htm (accessed Jan. 3, 2019).

Herceptin^® (trastuzumab) for injection for intravenous use [product information]. Revised: 11/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf (accessed Mar. 3, 2019).

Ricart  AD. Antibody-drug conjugates of calicheamicin derivative: gemtuzumab ozogamicin and inotuzumab ozogamicin. Clin Cancer Res. 2011;17(20):6417–6427.
[PubMed: 22003069] .

Besponsa (inotuzumab ozogamicin) injection for intravenous use [product information]. Revised: 08/2017. Wyeth Pharmaceuticals, Inc.; Philadelphia, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf (accessed Mar. 3, 2019).

Campath^® (alemtuzumab) Injection for intravenous use [product information]. Revised: 11/2018. Genzyme Corporation; Cambridge, MA Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103948s5167lbl.pdf (accessed Mar. 3, 2019).

Lemtrada^® (alemtuzumab) injection for intravenous use [product information]. Revised: 01/2019. Genzyme Corporation; Cambridge, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf (accessed Mar. 3, 2019).

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) [webpage]. Last Updated: 12/07/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm624247.htm (accessed Mar. 3, 2019).

Tecentriq^® (atezolizumab) injection for intravenous use [product information]. Revised: 6/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s010lbl.pdf (accessed Mar. 3, 2019).

FDA approves atezolizumab with chemotherapy and bevacizumab for first-line treatment of metastatic non-squamous NSCLC [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm627874.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients [webpage]. Last Updated: 07/05/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm612484.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA updates prescribing information for Keytruda and Tecentriq [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617378.htm (accessed Jan. 3, 2019).

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) [webpage]. Last Updated: 12/13/2018. Available from: U.S. Department of Health and Human Services, Food and Drug Administration. www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm301431.htm (accessed Feb. 21, 2019).

Bavencio^® (avelumab) injection for intravenous use [product information]. Revised: 10/2018. EMD Serono, Inc.; Rockland, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf (accessed Feb. 21, 2019).

Avastin (bevacizumab) injection for intravenous use [product information]. Revised: 06/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125085s323lbl.pdf (accessed Mar. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves bevacizumab in combination with chemotherapy for ovarian cancer [webpage]. Last Updated: 06/13/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610664.htm (accessed Jan. 3, 2019).

Blincyto^® (blinatumomab) injection for intravenous use [product information]. Revised: 3/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf (accessed Mar. 3, 2019).

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse [FDA News Release]. March 29, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm603151.htm (accessed Jan. 6, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia [webpage]. Last Updated: 03/29/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm603171.htm (accessed Jan. 3, 2019).

Brentuximab vedotin (Adcetris^®) [product information]. Revised: 11/2017. Seattle Genetics, Inc.; Bothell, WA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf (accessed Feb. 4, 2018).

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot [FDA News Release]. November 16, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626079.htm (accessed Jan. 4, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm626116.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: Brentuximab Vedotin[webpage]. Last Updated: 03/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm601947.htm (accessed Jan. 3, 2019).

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy [FDA News Release]. March 20, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm601935.htm (accessed Jan. 6, 2019).

Cinryze (C1 Esterase Inhibitor [Human]) For Intravenous Use, Freeze-Dried Powder for Reconstitution [product information]. Revised: 06/2018. Shire ViroPharma Incorporated; Lexington, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM129918.pdf (accessed Mar. 3, 2019).

Cimzia (certolizumab pegol) injection for subcutaneous use product information]. Revised: 05/2018 . UCB, Inc.; Smyrna, GA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125160s283lbl.pdf (accessed Mar. 3, 2019).

Coagadex^® (Coagulation Factor X (Human)) Lyophilized Powder for Solution and Intravenous Injection [product information]. Revised: 09/2018. BPL USA, Inc.; Durham, NC. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM468127.pdf (accessed Mar. 3, 2019).

Darzalex (daratumumab) injection for intravenous use [product information]. Revised: 6/2018. Janssen Biotech, Inc.; Needham, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s014lbl.pdf (accessed Mar. 3, 2019).

Xgeva (denosumab) injection for subcutaneous use [product information]. Revised: 06/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s191lbl.pdf (accessed Mar. 3, 2019).

Dupixent^® (dupilumab) injection for subcutaneous use [product information]. Revised: 10/2018. Regeneron Pharmaceuticals; Tarrytown, NY. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf (accessed Mar. 3, 2019).

Imfinzi^® (durvalumab) injection, for intravenous use [product information]. Revised: 2/2018. AstraZeneca Pharmaceuticals LP.; Wilmington, DE. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf (accessed Feb. 25, 2018).

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing [FDA News Release]. February 16, 2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm597217.htm (accessed Jan. 6, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves durvalumab after chemoradiation for unresectable stage III NSCLC [webpage]. Last Updated: 02/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm597248.htm (accessed Jan. 3, 2019).

Empliciti^® (elotuzumab) for injection for intravenous use [product information]. Revised: 11/2018. Bristol-Myers Squibb Co.; Princeton, NJ). Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761035s008lbl.pdf (accessed Mar. 3, 2019).

Magen  H, Muchtar  E. Elotuzumab: the first approved monoclonal antibody for multiple myeloma treatment. Ther Adv Hematol. 2016;7(4):187–195.
[PubMed: 27493709] ; PubMed Central PMCID: PMC4959642.

Hemlibra^® (emicizumab-kxwh) injection for subcutaneous use [product information]. Revised: 10/2018. Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf (accessed Mar. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm622564.htm (accessed Jan. 3, 2019).

Erelzi (etanercept-szzs) injection for subcutaneous use [product information]. Revised: 01/2018. SANDOZ; Princeton, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761042s001lbl.pdf (accessed Mar. 3, 2019).

McDonald  MR, Engelhardt  JM. Biologics blog: First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation. June 18, 2018. Available from: Patterson Belknap Webb & Tyler LLP. http://www.biologicsblog.com/first-decision-on-label-carve-outs-for-biosimilars-expected-in-enbrel-litigation (accessed Mar. 3, 2019).

Gemtuzumab ozogamicin injection for intravenous use (Mylotarg^TM) [product information]. Revised: 9/2017. Wyeth Pharmaceuticals, Inc.; Philadelphia, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf (accessed Feb. 18, 2018).

Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid [product information]. Revised: 3/2018. CSL Behring LLC.; Kankakee, IL. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM203150.pdf (accessed Mar. 3, 2019)

Xeomin (incobotulinumtoxinA) injection for intramuscular or intraglandular use [product information]. Revised: 7/2018. Merz North America, Inc.; Franksville, WI. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf (accessed Mar. 3, 2019).

Yervoy^® (ipilimumab) injection for intravenous use [product information]. Revised: 7/2018. BRISTOL MYERS SQUIBB; Princeton, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants accelerated approval to ipilimumab for MSI-H or dMMR metastatic colorectal cancer [webpage]. Last Updated: 07/11/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm613227.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma [webpage]. Last Updated: 04/16/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm (accessed Jan. 3, 2019).

Mircera^® (methoxy polyethylene glycol-epoetin beta) injection for intravenous or subcutaneous use [product information]. Revised: 6/2018. Vifor (International) Inc.; St. Gallen, Switzerland. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125164s078lbl.pdf

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves Mircera for anemia associated with chronic kidney disease in pediatric patients on dialysis [webpage]. Last Updated: 06/07/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610210.htm (accessed Jan. 3, 2019).

Opdivo (nivolumab) injection, for intravenous use [product information]. Revised: 1/2018. Bristol-Myers Squibb Company; Princeton, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s035s036s037s038s039lbl.pdf (accessed Mar. 1, 2018).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants nivolumab accelerated approval for third-line treatment of metastatic small cell lung cancer [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617370.htm (accessed Jan. 3, 2019).

Keytruda^® (pembrolizumab) injection, for intravenous use [product information]. Revised: 12/2018. Merck Sharp & Dohme Corp.; Whitehouse Station, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s037lbl.pdf (accessed Feb. 4, 2018).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab for Merkel cell carcinoma [webpage]. Last Updated: 12/19/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628867.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm625705.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab in combination with chemotherapy for first-line treatment of metastatic squamous NSCLC [webpage]. Last Updated: 12/17/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm624659.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA grants regular approval for pembrolizumab in combination with chemotherapy for first-line treatment of metastatic nonsquamous NSCLC [webpage]. Last Updated: 08/20/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617471.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab for treatment of relapsed or refractory PMBCL [webpage]. Last Updated: 06/13/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610670.htm (accessed Jan. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves pembrolizumab for advanced cervical cancer with disease progression during or after chemotherapy [webpage]. Last Updated: 06/13/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm610572.htm (accessed Jan. 3, 2019).

Nplate^® (romiplostim) for injection for subcutaneous use [product information]. Revised: 12/2018. Amgen Inc.; Thousand Oaks, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125268s163lbl.pdf (accessed Mar. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves romiplostim for pediatric patients with immune thrombocytopenia [webpage]. Last Updated: 12/14/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm628525.htm (accessed Jan. 3, 2019).

Leukine^® (sargramostim) injection for subcutaneous or intravenous use [product information]. Revised: 03/2018. Sanofi-Aventis U.S. LLC; Bridgewater, NJ. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf

Granix^® (tbo-filgrastim) injection for subcutaneous use [product information]. Revised: 07/2018. Teva Pharmaceuticals USA, Inc.; North Wales, PA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf (accessed Mar. 3, 2019).

Hematology/Oncology (Cancer) Approvals & Safety Notifications: FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma [webpage]. Last Updated: 05/03/2018. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm (accessed Jan. 3, 2019).

Actemra^® (tocilizumab) injection for intravenous or subcutaneous use (ACTPenTM) [product information]. Revised: 12/2018 Genentech, Inc.; South San Francisco, CA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf (accessed Mar. 3, 2019).

Vonvendi [von Willebrand factor (recombinant)] lyophilized powder for solution and intravenous injection[product information]. Revised: 2/2019. Baxalta US, Inc.; Lexington, MA. Available from: U.S. Department of Health and Human Services U.S. Food and Drug Administration. www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM476176.pdf (accessed Mar. 3, 2019).