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 treats patients with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

The BLA submission is based on data from IMvigor 210, an open-label, multicenter, single-arm Phase 2 study that evaluated the safety and efficacy of atezolizumab in patients with locally advanced or mUC, regardless of PD-L1 expression. 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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Analysis at 11.7 months of median follow-up demonstrated that atezolizumab shrank tumors (ORR) in 15% (95% CI: 11, 19) of patients whose disease progressed after platinum-based chemotherapy (n=310). In addition, atezolizumab shrank tumors in 26% (95% CI: 18, 36) of patients whose disease had medium and high levels of PD-L1 expression (n=100).

Genentech is also conducting an ongoing, confirmatory Phase 3 study, IMvigor 211, which comparesatezolizumab to chemotherapy in patients whose bladder cancer has progressed on at least one prior platinum-containing regimen. The FDA has set a target date of September 12, 2016 to make a decision on the BLA.

Atezolizumab is an investigational monoclonal antibody designed to bind to programmed death ligand-1 (PD-L1) and block its interactions to PD-1 and B7.1 receptors.

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