Genentech announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for atezolizumab (anti-PDL1; MPDL3280A). Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.
The BLA is supported by data from the BIRCH study, an open-label, multicenter, single-arm Phase 2 trial that evaluated the safety and efficacy of atezolizumab in 667 patients with locally advanced or metastatic NSCLC whose disease expressed PD-L1. The primary endpoint was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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This is the second BLA acceptance and Priority Review for atezolizumab, in addition to the first 1 for the advanced or metastatic urothelial carcinoma (mUC) indication. The FDA will make a decision on this BLA approval by October 19, 2016.
Atezolizumab is an investigational monoclonal antibody designed to directly bind to programmed death ligand-1 (PD-L1) expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors.
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