Pfizer’s Avelumab Poised For Speedy Review By FDA

Nov 29 2016

• By Jessica Merrill

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Avelumab could be the fourth PD-1/L1 inhibitor to reach the market now that the US FDA has accepted Pfizer’s and Merck KGaA’s BLA for priority review in the treatment of metastatic Merkel cell carcinoma.

Pfizer Inc. and Merck KGAA’s PD-L1 inhibitor avelumab appears on track to be the fourth anti-PD-1/L1 antibody to reach the market and the first for metastatic Merkel cell carcinoma. The companies announced Nov. 29 that a BLA for avelumab was accepted for priority review for the treatment of metastatic MCC, positioning the cancer immunotherapy for FDA approval in the first part of 2017.

Avelumab is the cornerstone of Pfizer’s strategy to become a leader in the field of immuno-oncology and getting the drug...

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