Merck receives priority review from FDA for new drug application for HIF-2α inhibitor belzutifan (MK-6482)

Merck/MSD

16 March 2021 - Application based on objective response rate from Phase 2 trial evaluating belzutifan in patients with von Hippel-Lindau disease associated renal cell carcinoma.

Merck today announced that the U.S. FDA has accepted and granted priority review for a new drug application for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan, a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma, not requiring immediate surgery.

Read Merck press release 

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier