Merck Gets FDA Expanded Keytruda OK in Some Kidney Cancer Patients
November 18 2021 - 7:48AM
Dow Jones News
By Colin Kellaher
Merck & Co. on Thursday said the U.S. Food and Drug
Administration approved the expanded use of its blockbuster cancer
drug Keytruda as an adjuvant therapy for certain renal cell
carcinoma patients following surgery.
The Kenilworth, N.J., drugmaker said the approval covers
patients at intermediate-high or high risk of recurrence following
nephrectomy, or following nephrectomy and resection of metastatic
lesions.
Merck said the approval is based on data from a Phase 3 study in
which Keytruda showed a statistically significant improvement in
disease-free survival, reducing the risk of disease recurrence or
death by 32% compared to placebo.
Renal cell carcinoma is the most common type of kidney cancer,
accounting for roughly 90% of 10 kidney cancer diagnoses.
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
November 18, 2021 07:33 ET (12:33 GMT)
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