Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

July 29, 2020 Auto Bot Breakthrough Therapy Designation, FDA, Latest, Merck, patients, Pharma, receives, regulatory, Renal Cell Carcinoma, Treat 0

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  • The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required
  • The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint
  • MK-6482 (formerly PT2977) is an investigational oral HIF-2α inhibitor, currently being evaluated in a P-III  trial in advanced RCC (NCT04195750), a P-II trial in VHL-associated RCC (NCT03401788), and a P-I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738)

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