Merck Says Health Canada Granted Approval For KEYTRUDA To Treat Renal Cell Carcinoma

Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, announced Wednesday that Health Canada has granted approval for KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

This approval is based on the results from the Phase 3 KEYNOTE-564 trial, which demonstrated a statistically significant improvement in disease-free survival.

RCC is the most common type of kidney cancer, making up for more than 90% of cases of kidney cancer.

Health Canada's approval is based on findings from KEYNOTE-564, a Phase 3 randomized, double-blind clinical trial that enrolled 994 patients. The primary efficacy outcome measure was investigator-assessed disease-free survival (DFS).

The results of KEYNOTE-564 demonstrated a statistically significant improvement in DFS for patients randomized to receive KEYTRUDA monotherapy compared with patients randomized to placebo.

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