FDA Approves First Immunotherapy for Breast Cancer

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 new approval of the combination is based on safety and efficacy results from the multicenter IMpassion130 trial, which were presented at the European Society for Medical Oncology (ESMO) 2018 Congress and simultaneously published in the New England Journal of Medicine.

The trial randomly assigned 451 patients with locally advanced or metastatic triple-negative breast cancer patients to atezolizumab and 451 to placebo. All 902 patients also received nab-paclitaxel.

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