The FDA will speed up the review of Keytruda to treat patients with kidney cancer after they’ve undergone surgery.
The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) for the post-surgery treatment of patients with renal cell carcinoma (RCC) whose disease is at intermediate- or high-risk of recurrence after nephrectomy or after the nephrectomy and resection of metastatic legions, according to Merck, the manufacturer of the immunotherapy agent.
“The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio,” said Dr. Scot Ebbinghaus, vice president of clinical research at Merck Research Laboratories.
The priority review – which will speed up the FDA’s review and potential approval of the regimen – was based on findings from the phase 3 KEYNOTE-564 clinical trial. The 994 patients involved in the study were randomized to receive either 200 mg of intravenous (IV) Keytruda on day 1 of a three-week cycle for up to 17 cycles or placebo.
Trial results showed that Keytruda led to a clinically meaningful improvement in disease-free survival (DFS) compared to placebo. Estimated DFS rates at 12 months were 85.7% and 76.2% for the Keytruda and placebo groups, respectively and 77.3% and 68.1%, respectively, at 24 months.
Side effects occurred in 79.1% and 53.4% of patients in the Keytruda and placebo groups, respectively, though the majority were not serious (grade 1 or grade 2). Common side effects were fatigue, pruitis (skin irritation), hypothyroidism, diarrhea, rash, hyperthyroidism, joint pain, nausea, myalgia and asthenia (weakness or lack of energy).
The FDA must decide on the approval by Dec. 10, 2021.
“We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to appropriate patients with renal cell carcinoma in the U.S.,” Ebbinghaus said.
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