Breakthrough therapy designation granted to treatment for patients with von Hippel-Lindau disease-associated RCC
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482 (Merck) for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required, according to a company press release. Orphan drug designation was also granted to MK-6482 for VHL disease.
“Merck’s diverse and expansive oncology pipeline is focused on bringing forward innovative new treatments to patients in need and continues to show important progress,” said Dr Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories, in a press release. “These designations for MK-6482 support the potential of targeting HIF-2α in certain patients with von Hippel-Lindau disease, who currently have limited treatment options and face an increased risk for benign tumors as well as several types of cancer, including renal cell carcinoma.”
Read the full press release here.