- 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 (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.