pharmaphorum December 15, 2023
The FDA has approved MSD’s oral HIF-2 alpha inhibitor Welireg for a second cancer indication, relapsed or refractory advanced renal cell carcinoma (RCC), the most common form of kidney cancer.
The green light comes two years after Welireg (belzutifan) became the first drug in the class to be approved for marketing, initially for von Hippel-Lindau (VHL) disease, an inherited condition that can cause tumours to develop in various organs of the body.
MSD – known as Merck & Co in North America – acquired Welireg as part of its $2.2 billion takeover of Peloton Therapeutics in 2019, which included an upfront payment of $1.05 billion.
The approval in RCC is for patients previously treated with PD-1/L1 and VEGF-targeted therapies, and...