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HIF-2α inhibitor MK-6482 receives FDA Breakthrough Designation for Von Hippel-Lindau Disease-associated RCC

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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.

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