Merck KGaA, Pfizer Receive Positive EMA Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma

Merck KGaA

and Pfizer

today announced that the European Medicines Agency (EMA)'s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, pending an official decision by the European Commission (EC), expected in December. The COMP positive opinion is for the cancer immunotherapy avelumab, for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 Each year, there are approximately 2,500 new cases of MCC diagnosed in the European Union (EU).3 There is currently no therapy approved specifically for the treatment of metastatic MCC.4 "While significant therapeutic advances have