The FDA accepts under Priority Review the Biologics License Application (BLA) from Merck KGaA's (OTCPK:MKGAF)(OTCPK:MKGAY) EMD Serono unit seeking approval of avelumab for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a Breakthrough Therapy, Fast Track and Orphan Drug designation.
MCC is a rare and aggressive type of skin cancer that affects ~2,500 Americans each year.
Priority Review status shortens the review clock to six months from the usual 10 months. The specific action date is not provided but should be around June 1, 2017.
Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer (NYSE:PFE) for the treatment of a range of cancers under a strategic alliance inked in November 2014.
The marketing application in Europe is currently under review.