Avelumab regulatory update

Merck and Pfizer said FDA accepted and granted Priority Review to a BLA for avelumab 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 expects an FDA decision in May 2017. In October, EMA accepted an MAA for avelumab to treat metastatic MCC (see BioCentury, Nov. 7). Both submissions include data from the pivotal Phase II JAVELIN Merkel 200 trial, which evaluated the compound in patients whose disease progressed after ≥1 chemotherapy treatment (see BioCentury, May 23)...