Shots:

• 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)

­ Ref: Merck | Image: Merck