FDA Grants Priority Review to Pembrolizumab as Adjuvant Therapy for Renal Cell Carcinoma


If approved, pembrolizumab would be the first adjuvant immunotherapy option for this patient population with renal cell carcinoma.

Pembrolizumab (Keytruda, Merck) has been granted priority review by the FDA for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

The supplemental Biologics License Application is based on findings from the pivotal phase 3 KEYNOTE-564 trial, which found a statistically significant and clinically meaningful improvement in disease-free survival compared to placebo. The FDA has set a Prescription Drug User Fee Act date of December 10, 2021.

KEYNOTE-564 is a randomized, double-blind, phase 3 trial investigating the use of pembrolizumab as a monotherapy for the adjuvant treatment of patients with RCC who have intermediate-high risk, high-risk, or M1 no evidence of disease RCC with clear cell component. The study enrolled 994 patients who received either placebo or pembrolizumab 200 mg intravenously on day 1 of each 3-week cycle for up to 17 cycles. Disease-free survival is the primary endpoint, and secondary endpoints include overall survival and safety.

Pembrolizumab is an anti-programmed death receptor-1 (PD-1) therapy that increases the ability of the immune system to help detect and fight tumor cells. It blocks the interaction between PD-1 and its ligands, thereby activating T lymphocytes that can affect both tumor cells and healthy cells. If approved, it would be the first adjuvant immunotherapy option for patients with RCC.

“We look forward to working with the FDA toward the goal of bringing the first adjuvant immunotherapy option to appropriate patients with renal cell carcinoma in the US,” said Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, in a press release.

Pembrolizumab is already approved in combination with axitinib for the first-line treatment of patients with advanced RCC and is continuing to be investigated across multiple settings and stages of disease, including adjuvant and advanced or metastatic disease. The clinical development program exploring pembrolizumab in RCC includes more than 20 studies and more than 4000 patients globally.


FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for Keytruda (Pembrolizumab) as Adjuvant Therapy in Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery. News release. Merck; August 10, 2021. Accessed August 11, 2021. https://www.merck.com/news/fda-grants-priority-review-to-mercks-supplemental-biologics-license-application-for-keytruda-pembrolizumab-as-adjuvant-therapy-in-certain-patients-with-renal-cell-carcinoma-rcc-foll/

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