Posted by Michael Wonder on 29 Jul 2020
FDA grants breakthrough therapy designation to Merck’s novel HIF-2α inhibitor MK-6482 for treatment of certain patients with von Hippel-Lindau disease-associated renal cell carcinoma
29 July 2020 - Reinforces important progress in Merck’s oncology pipeline to advance novel therapeutic candidates.
Merck announced today that the U.S. FDA has granted breakthrough therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with non-metastatic RCC tumours less than three centimetres in size, unless immediate surgery is required.
The FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a Phase 2 trial evaluating MK-6482 in patients with VHL-associated clear cell RCC, which were presented at the 2020 American Society of Clinical Oncology Annual Meeting.
