Merck KGaA, Darmstadt, Germany, and Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.
"The EC's decision is significant for BAVENCIO and, more importantly, for European patients living with this very challenging skin cancer," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which operates as EMD Serono in the US and Canada. "Our alliance with Pfizer continues to demonstrate the power of working together, and we are grateful to everyone who has helped to bring the first and only approved immunotherapy for mMCC to European patients."
"This European approval further establishes our continued momentum, building on the accelerated approvals BAVENCIO received in the US earlier this year," said Liz Barrett, Global President, Pfizer Oncology. "Importantly, we are now one step closer to our goal of making BAVENCIO available to patients around the world."
Approximately 2,500 Europeans are affected by MCC each year, with metastatic disease diagnosed in 5-12% of patients with MCC. Fewer than 20% of patients with metastatic MCC survive beyond 5 years.
"Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease," said Dirk Schadendorf, MD, Director of Dermatology, University Hospital Essen, Germany. "This approval is a meaningful development for patients and their families suffering from this devastating disease."
