Keytruda Nabs FDA Priority Reviews for Two Cancer Indications

May 11, 2021

The FDA has granted Merck priority reviews for its blockbuster cancer drug Keytruda (pembrolizumab) alongside Lenvima (lenvatinib) for endometrial and renal cell carcinoma.

Merck is hoping to see Keytruda, an anti-PD-1 immunotherapy, approved for treating patients with advanced endometrial carcinoma who experience disease progression after prior systemic therapy and are not candidates for curative surgery or radiation. It’s also pursuing approval for first-line treatment of patients with advanced renal cell carcinoma.

The agency’s priority reviews mean that it will act to make a decision on the two applications within six months compared to the 10 months it normally takes for standard reviews. It intends to make a call by Aug. 25 for the advanced renal cell carcinoma indication and issue a decision by Aug. 26 for the advanced endometrial carcinoma indication.

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