9 May 2017 - Second approval for Bavencio in less than two months.

EMD Serono and Pfizer today announced that the US FDA has approved Bavencio (avelumab) 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 adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma. These indications are approved under accelerated approval based on tumour response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read Pfizer press release