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.
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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