Medication Monitor

Generic Name (Trade Name—Company)
March 13, 2019


Accelerated approval granted for treatment of triple-negative breast cancer

FDA granted accelerated approval to atezolizumab plus chemotherapy (nab-paclitaxel [Abraxane]) for treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TBNC) whose tumors express PD-L1, as determined by an FDA-approved test.

Accelerated approval was based on data from a Phase III study demonstrating that atezolizumab plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 40% compared with nab-paclitaxel alone in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. 

The most common adverse effects of atezolizumab plus nab-paclitaxel were low white blood cell count, tingling or numbness in the hands and feet, decreased neutrophil count, fatigue, low red blood cell count, low blood potassium levels, pneumonia, and increased AST levels.