Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

Shots:The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL)Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm…

ByRidhi RastogiMay 15, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 5 Biologics and 2 New Chemical Entities in February 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Welireg to treat Von Hippel-Lindau & Renal Cell Carcinoma PharmaShots has compiled a list of 6 drugs…

ByDipanshu DixitMarch 18, 2025

NEWS

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots:The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…

ByDipanshu DixitFebruary 19, 2025

NEWS

Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots: The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25 Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…

ByDipanshu DixitDecember 13, 2024

Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

EMA Marketing Authorization of New Drugs in February 2025

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

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