Article

FDA Grants Keytruda Priority Review for Kidney Cancer Treatment

Author(s):

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.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.

Related Videos
CURE spoke with Dr. William C. Huang about what kind of team may be required to treat a patient with metastatic kidney cancer.
Image of man wearing baseball cap backwards.
Dr. Emre Yekedüz highlighted strategies that may improve patients' quality of life and mitigate treatment-related side effects in renal cell carcinoma.
Dr. Guru Sonpavde emphasized the importance of better understanding how genetic mutations influence the treatment of cancer care, particularly GU cancers.
Image of doctor with brown hair.
Image of man with black hair.
.Dr. Catherine Wu, chief of the Division of Stem Cell Transplantation and Cellular Therapies at Dana-Farber Cancer Institute, and institute member at the Broad Institute of MIT and Harvard, in Boston
Dr. Katy Beckermann discusses how a Fotivda and Opdivo combination for renal cell carcinoma compared with Fotivda alone based on patient feedback.
Dr. Catherine Wu is chief of the Division of Stem Cell Transplantation and Cellular Therapies at Dana-Farber Cancer Institute, and institute member at the Broad Institute of MIT and Harvard, in Boston, Massachusetts.
Dr. Alan Tan is the GU Oncology Lead at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, as well as an associate professor in the Division of Hematology/Oncology at Vanderbilt University Medical Center and GU Executive Officer with the Alliance for Clinical Trials in Oncology.
Related Content