FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Merck and Pfizer’s Bavencio Collaboration Nabs FDA Approval in Bladder Cancer

May 17, 2017
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The FDA has approved Merck and Pfizer’s jointly developed Bavencio injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Bavencio was previously granted accelerated approval from the FDA for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma.

The drug is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, Bavencio is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses.

The indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for the indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

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