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FDA Grants Second Approval for BAVENCIO (avelumab)

May 9, 2017
May 9, 2017- The U.S. Food and Drug administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc. and Pfizer Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.