Merck Reports the US FDA’s Acceptance of sNDA and Granted Priority Review of Welireg (belzutifan) for Advanced Renal Cell Carcinoma
Shots:
- The US FDA has accepted and granted priority review for sNDA seeking approval for Welireg (HIF-2α inhibitor) for adult patients with advanced RCC following immune checkpoint and anti-angiogenic therapies. The US FDA’s decision is expected in Jan 2024
- The sNDA was based on the results from the P-III trial (LITESPARK-005) evaluating Welireg (120mg, qd) vs everolimus (10mg, qd) in 746 patients which showed a significant clinical improvement in PFS based on a pre-specified interim analysis along with improvement in 2EPs of ORR
- Welireg, the first HIF-2α inhibitor therapy approved in the US is currently approved for adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas, or pancreatic NETs not requiring immediate surgery
Ref: Businesswire | Image: Merck
Related News:- Merck Reports P-III Trial (LITESPARK-005) Results of Welireg (belzutifan) for Patients with Advanced Renal Cell Carcinoma
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