FDA approves Bavencio, first therapy for MCC

FDA granted accelerated approval to Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) to treat metastatic Merkel cell carcinoma. The mAb against PD-L1 is the first therapy FDA has approved to treat the disease. Bavencio is now available at a wholesale acquisition cost (WAC) of about $13,000 per month, Pfizer spokesperson Sally Beatty told BioCentury.

Bavencio is under review in the EU for the same indication. FDA has also granted Priority Review to a BLA for the drug to treat bladder cancer, with a PDUFA date of Aug. 27 (see BioCentury Extra, Feb. 28)...