FDA Accepts BLA for Avelumab for Treatment of MCC for Priority Review (PFE)
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FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review
November 29, 2016 8:18 AM ESTROCKLAND, Massachusetts and NEW YORK, November 29, 2016 /PRNewswire/ --
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If approved by the FDA, avelumab, an investigational immunotherapy, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma (MCC)Â Â Avelumab has previously received FDA Breakthrough Therapy and Fast Track Designations for metastatic MCC, as well as FDA Orphan Drug Designation for MCCÂ ÂEMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the... More
