FDA Approves First Immunotherapy for Breast Cancer

Nick Mulcahy

March 08, 2019

The US Food and Drug Administration today granted accelerated approval to atezolizumab (Tecentriq, Genentech/Roche) plus the chemotherapy nab-paclitaxel (Abraxane, Celgene) for the first-line treatment of unresectable locally advanced or metastatic, PD-L1-positive triple-negative breast cancer (TNBC).

Atezolizumab is the first immunotherapy to be approved for breast cancer.

The approval is based on progression-free survival results and continued approval may be contingent upon confirmatory trial data.

The investigators reported that adverse events (AEs) were consistent with the safety profiles of the study drugs; no new safety signals were identified with the combination of atezolizumab plus nab-paclitaxel.

PACI Institute