EMA validates MAA for avelumab to treat Merkel cell carcinoma.- Merck KGaA + Pfizer

Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) has validated for review Merck�s Marketing Authorization Application (MAA) for avelumab , for the proposed indication of metastatic Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, which impacts approximately 2,500 Europeans a year.

Validation of the MAA confirms that submission is complete and begins the EMA�s centralized review process. If approved, avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, could be the first approved treatment indicated for metastatic MCC in the EU. Patients with metastatic MCC face a very poor prognosis, with less than 20 percent surviving beyond five years.