Merck: FDA Accepts Two Applications for Expanded Keytruda Use
August 10 2021 - 7:25AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 10, 2021 07:12 ET (11:12 GMT)
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