Merck: FDA Accepts Two Applications for Expanded Keytruda Use

By Colin Kellaher

Merck & Co. on Tuesday said the U.S. Food and Drug Administration accepted a pair of applications for expanded use of its blockbuster cancer drug Keytruda.

The Kenilworth, N.J., drugmaker said the agency granted priority review to its application for Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Merck said the agency set a target action date of Dec. 10 for the new renal cell carcinoma indication.

Merck said the FDA also accepted its application for the use of Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and aren't candidates for curative surgery or radiation.

The second application has an FDA target action date of March 28, 2022.

Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved for at least 30 indications in the U.S.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 10, 2021 07:12 ET (11:12 GMT)

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