The hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate, received Breakthrough Designation from FDA for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.
HIF-2α inhibitor MK-6482 is sponsored by Merck.
FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a phase II trial evaluating MK-6482 in patients with VHL-associated clear cell RCC.
