FDA grants priority review to belzutifan for renal cell carcinoma subset
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The FDA granted priority review to belzutifan for treatment of certain patients with renal cell carcinoma.
The designation applies to use of belzutifan (MK-6482, Merck) — a hypoxia-inducible factor-2 alpha inhibitor — for patients with von Hippel-Lindau disease-associated renal cell carcinoma who do not require immediate surgery.
An estimated 200,000 people worldwide, including 10,000 people in the United States, have von Hippel-Lindau disease.
“Von Hippel-Lindau disease is a rare genetic condition for which there is no systemic treatment option available and is associated with a high risk of cancer development in multiple organs,” Scot Ebbinghaus, MD, vice president for clinical research with Merck Research Laboratories, said in a company-issued press release. “In fact, up to 70% of patients with [von Hippel-Lindau disease] develop renal cell carcinoma during their lifetime.”
Merck’s new drug application is based on results of the phase 2 Study-004 trial, which included 61 patients. Objective response rate among patients with von Hippel-Lindau disease-associated renal cell carcinoma served as the primary endpoint.
Results showed a confirmed ORR of 36.1% (95% CI, 24.2-49.4).
The FDA is expected to make a decision on the application by Sept. 15.
Merck also is evaluating belzutifan in phase 3 trials as monotherapy and as part of combination therapy for previously treated patients, and as part of combination first-line therapy for advanced clear cell renal cell carcinoma.
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