Carcinoma of the Female Breast
In 2020, the FDA approved neratinib (in combination with capecitabine) and margetuximab, a monoclonal antibody similar to trastuzumab that is designed to improve the antibody dependent cellular cytotoxicity mechanism of action when used with chemotherapy.
In 2020, pembrolizumab, a second immune checkpoint inhibitor, was FDA approved for use in patients with PD-L1 positive disease in combination with chemotherapy (taxane or gemcitabine/carboplatin) based on results from the KEYNOTE 355 trial showing an improved median progression-free survival with the addition of this antibody to standard chemotherapy.
Sacituzumab govitecan (TRODELVY) is the first antibody drug conjugate approved for triple negative breast cancer.
The phase 3 confirmatory trial, ASCENT, demonstrated that sacituzumab govitecan is associated with a statistically significant improvement in progression-free and overall survival when compared to single-agent chemotherapy in patients with triple negative breast cancer who had received at least two prior lines of standard chemotherapy for metastatic disease.