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eChapter 2019: Goodman & Gilman Year in Review New and Noteworthy FDA Regulatory Actions

Nelda Murri

PART 2: OTHER NOTEWORTHY FDA REGULATORY ACTIONS

Abbreviations

BLA: Biologic license application

FDA: U.S. Food and Drug Administration

NDA: New drug application

 

Note: The following symbols are used throughout.

! accelerated approval (final FDA approval is contingent on demonstration of a clinical benefit in a confirmatory trial)

biologic license designation

$ breakthrough therapy

# cancer drug

† orphan indication

In the first half of 2019, the FDA granted 11 noteworthy NDA licenses and approved 14 noteworthy new BLAs. Part 1 of this series looked back at first-in-class and "me-too" NDA and BLA approvals, breakthrough ($) therapies, orphan indications (†), cancer drugs (#), and companion diagnostics for precision cancer therapy. The remaining noteworthy FDA accomplishments are compiled in this part of the series, including dosing and other labeling changes approved for established drugs (Table P2–1), approved follow-on products, pediatric and pregnancy labeling changes, and other noteworthy FDA regulatory accomplishments related to drug efficacy and safety.

Table P2-1Marketed Drugs With Notable Labeling Changes Approved January-June, 2019
View Table||Download (.pdf)
Table P2-1 Marketed Drugs With Notable Labeling Changes Approved January-June, 2019
Drug Pharmacology Labeling Change Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th Edition Reference

Ado-trastuzumab emtansine¶# (KADCYLA)1,2

HER2-targeted monoclonal antibody and microtubule inhibitor conjugate

New use: Adjuvant treatment of HER2+ early breast cancer$ with residual invasive disease after neoadjuvant treatment3,4

Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules > Ado-trastuzumab Emtansine

Atezolizumab¶# (TECENTRIQ)5–7

Programmed death receptor-1 blocking antibody

  • New uses: (1) Combination treatment of unresectable locally advanced/metastatic PD-L1+ (as detected by an approved companion test) triple-negative breast cancer (TNBC)!,8,9; (2) first-line combination treatment for extensive-stage small cell lung cancer†,10,11

  • New companion test: Ventana PD-L1 (SP142 Assay) for TNBC12

  • Revised dosage regimens: 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks for (1) non-small cell lung cancer, as a single agent or following completion of 4–6 cycles of carboplatin-paclitaxel, and if bevacizumab is discontinued13; (2) small cell lung cancer following completion of 4 cycles of carboplatin-etoposide13; and (3) urothelial carcinoma14

Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules > Atezolizumab

Avatrombopag (DOPTELET)15

Thrombopoietin receptor agonist

New use: Treatment-resistant idiopathic thrombocytopenic purpura†,16,17

Chapter 41. Hematopoietic Agents: Growth Factors, Minerals, and Vitamins > Thrombopoietin

Avelumab¶# (BAVENCIO)18,19

Programmed death ligand-1 blocking antibody

New use: In combination with axitinib for first-line treatment of advanced renal cell carcinoma$,20,21

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