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Avelumab Receives Fast-Track for Merkel Cell Carcinoma

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The PD-L1 inhibitor was granted orphan drug status just last month.

A new PD-L1 inhibitor being developed by Pfizer and Merck has been placed on the Fast Track by the FDA. Avelumab is a fully humanized anti-PD-L1 monoclonal antibody being developed for metastatic Merkel cell carcinoma (MCC), an aggressive form of skin cancer. Just last month, the 2 companies published a joint press release announcing the orphan drug designation for avelumab.

The drug continues to be evaluated in a phase 2 study (JAVELIN Merkel 200) to assess safety and efficacy in in patients with metastatic MCC who have progressed after at least 1 prior chemotherapy regimen. The trial program for JAVELIN is simultaneoulsy testing the drug in patients with non-small cell lung cancer who have progressed on platinum-containing doublet therapy and in patients with advanced solid tumors.

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