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FDA grants fast track status for Merck and Pfizer’s carcinoma drug avelumab

by JMC on October 9, 2015

The US Food and Drug Administration (FDA) has granted fast track designation for Merck and Pfizer’s investigational anti-PD-L1 IgG1 monoclonal antibody, avelumab, to treat metastatic Merkel cell carcinoma (MCC).

In September, the FDA granted orphan drug designation for avelumab, to treat MCC, a rare and aggressive type of skin cancer.

The fast track status is designed to facilitate development and expedite the review of drugs to treat serious conditions and address an unmet medical need.

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