Priority Review for avelumab in metastatic MCC

Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) said FDA accepted and granted Priority Review to a BLA for avelumab (MSB0010718C) to treat metastatic Merkel cell carcinoma. The partners said the mAb against PD-L1 would be the first therapy approved in the U.S to treat the disease. Pfizer spokesperson Sally Beatty told BioCentury the company expects a decision from FDA in May 2017.

Last month, Merck and Pfizer said EMA accepted an MAA for avelumab in the same indication. Both submissions include data from the pivotal Phase II JAVELIN Merkel 200 trial, which evaluated the compound in patients whose disease has progressed after at least one chemotherapy treatment (see BioCentury Extra, Oct. 31)...