FDA grants priority review to Keytruda for renal cell carcinoma subset
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The FDA granted priority review to pembrolizumab as adjuvant therapy for certain patients with renal cell carcinoma, according to the agent’s manufacturer.
The designation applies to use of the agent by patients at intermediate-high or high risk for recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
Pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, is approved in the United States for several cancer indications, including in combination with the VEGF-targeted tyrosine kinase inhibitor axitinib (Inlyta, Pfizer) for first-line treatment of advanced renal cell carcinoma.
The FDA based the priority review designation on results of the randomized phase 3 KEYNOTE-564 trial, which included 994 patients with renal cell carcinoma who underwent nephrectomy and had intermediate-high risk, high-risk, or M1 no evidence of disease renal cell carcinoma with clear cell component.
Researchers randomly assigned patients to 200 mg pembrolizumab or placebo on day 1 of each 3-week cycle for up to 17 cycles.
DFS served as the primary endpoint. Secondary endpoints included OS and safety.
As Healio previously reported, results presented at this year’s virtual ASCO Annual Meeting showed pembrolizumab-treated patients achieved significantly longer DFS.
The FDA is expected to make a decision on approval of this indication by Dec. 10.
“The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio,” Scot Ebbinghaus, MD, vice president of clinical research for Merck Research Laboratories, said in a company-issued press release. “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 U.S.”
The FDA also accepted a supplemental biologics license application seeking approval of pembrolizumab as monotherapy for certain women with advanced endometrial carcinoma. The application applies to use of the agent by women with microsatellite instability-high or mismatch repair-deficient endometrial carcinoma whose disease progressed after prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
The FDA is expected to make a decision on the endometrial cancer indication by March 28.
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