7 October 2015 - Merck KGaA and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. This announcement builds on the recent FDA Orphan Drug designation that was granted for avelumab on September 21, 2015 for the treatment of MCC. The Fast Track designation is designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and address an unmet medical need.

“We are pleased that the FDA continues to acknowledge the current high unmet needs for patients with metastatic Merkel cell carcinoma through these recent regulatory designations for avelumab,” said Dr. Luciano Rossetti, Global Head of Research & Development of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. “We look forward to working closely with the FDA on an expedited review process for avelumab, and we hope to be able to provide a potential new treatment option for patients with this difficult-to-treat cancer in the future.”

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