October 31, 2016
KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC). It is an aggressive and rare skin cancer, which impacts approximately 2,500 Europeans a year. If approved, avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, could be the first approved treatment in the EU indicated for metastatic MCC. Metastatic MCC patients face a very poor prognosis, with less than 20 percent surviving beyond five years.
Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono, said: “While early-stage Merkel cell carcinoma can be generally managed with surgery, there are significant unmet needs in metastatic disease, where treatment options are severely limited. We are pleased that the EMA is initiating its review of avelumab, as this means we are one step closer to bringing a much-needed new treatment option to European patients.”
“This is the first of what we hope will be many regulatory milestones for avelumab. We are committed to evaluating avelumab in a number of hard-to-treat cancers, and we believe it may have potential to be an important treatment option for patients with metastatic Merkel cell carcinoma,” said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development.