- The FDA designates Orphan Drug-tagged avelumab for Fast Track review for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. Avelumab, currently in Phase 2 development for MCC, is a fully human anti-PD-L1 IgG1 monoclonal antibody. It is being co-developed and co-commercialized by Merck KGaA (OTCPK:MKGAF) (OTCPK:MKGAY) and Pfizer (NYSE:PFE) under their November 2014 strategic alliance.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the NDA.