EMA validates Merck KGaA and Pfizer's MAA for avelumab

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC).

If approved, this investigational anti-PD-L1 IgG1 monoclonal antibody being developed by Germany’s Merck KGaA (MRK: DE) and US pharma giant Pfizer (NYSE: PFE), could be Europe’s first treatment for metastatic MCC, a rare and aggressive skin cancer which impacts around 2,500 Europeans annually.

Affected patients currently face a very poor prognosis, with less than 20% surviving beyond five years.