21 September 2017 - Approval is based on data from the Javelin Merkel 200 study including durable tumor response rate and duration of response.
Merck KGaA and Pfizer today announced that the European Commission has granted marketing authorisation 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 authorisation in the 28 countries of the European Union 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.