Merck KGaA, Germany, and Pfizer Inc. today 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. Bavenciois 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.”
The EC’s decision follows the US Food and Drug Administration’s (FDA) accelerated approval for Bavencio earlier this year.
“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.”
The clinical development program for Bavencio, known as Javelin, involves at least 30 clinical programs and more than 6,300 patients evaluated across more than 15 different tumor types. In addition to mMCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, emelanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial carcinoma.