FDA Approves First Immunotherapy for Breast Cancer
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.