The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine kinase inhibitor (TKI). Initially registered in the US in 2021 for the treatment of certain von Hippel-Lindau (VHL) disease-associated tumors, the HIF-2α inhibitor has now gained additional approval for RCC.
The RCC approval was bolstered by data from a late-stage trial that achieved its coprimary endpoint of progression-free survival (PFS), with Welireg demonstrating a 25% reduction in the risk of disease progression or death compared to everolimus. Additionally, the objective response rate (ORR) saw a significant increase to 22% with Welireg, up from 4% with everolimus.- Flcube.com
