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)

Copyright (c) 2021 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Merck Charts.
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Merck Charts.