WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has conditionally approved WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; The treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies. The EC approval of these two
https://www.merck.com/news/welireg-belzutifan-receives-first-european-commission-approval-for-two-indications/
FDA Grants Priority Review to Merck’s Application for WELIREG® (belzutifan) for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (PPGL)
Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL If approved, WELIREG would be the only available therapy in the U.S. for eligible patients with advanced PPGL Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL). The sNDA is based on objective response rate (ORR) and duration of response (DOR) data from the Phase 2 LITESPARK-015 trial, which will be presented at an upcoming medical meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target
https://www.merck.com/news/fda-grants-priority-review-to-mercks-application-for-welireg-belzutifan-for-the-treatment-of-patients-with-advanced-pheochromocytoma-and-paraganglioma-ppgl/
Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma
If approved, WELIREG would be the first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor available for these patients in the European Union Positive opinion granted based on data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional approval of WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; The treatment of adult patients with advanced clear cell renal cell carcinoma (RCC)
https://www.merck.com/news/merck-receives-positive-eu-chmp-opinion-for-welireg-belzutifan-as-treatment-for-adult-patients-with-certain-types-of-von-hippel-lindau-disease-associated-tumors-and-for-certain-previously-trea/
Merck’s WELIREG® (belzutifan) Approved in China for the Treatment of Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
WELIREG is the first and only systemic therapy approved in China for adult patients with certain VHL disease-associated tumors Decision marks first approval for WELIREG in China and 17th approval of WELIREG for these patients globally Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) in China has approved WELIREG ® (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. WELIREG is a first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor and is the first and only approved HIF-2α inhibitor in China. This approval is based on objective response rate (ORR) and median duration of response (DOR) results from the Phase 2 LITESPARK-004 trial and is the 17th approval
https://www.merck.com/news/mercks-welireg-belzutifan-approved-in-china-for-the-treatment-of-adult-patients-with-certain-types-of-von-hippel-lindau-vhl-disease-associated-tumors/
Exelixis and Merck Sign Clinical Development Collaboration to Evaluate Investigational Zanzalintinib in Combination With KEYTRUDA® (pembrolizumab) in Head and Neck Cancer and in Combination With WELIREG® (belzutifan) in Renal Cell Carcinoma
ALAMEDA, CALIF. & RAHWAY, N.J., Oct. 14, 2024 – Exelixis, Inc. (Nasdaq: EXEL) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck’s anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) in a Phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma (HNSCC), and zanzalintinib with WELIREG ® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in a Phase 1/2 trial and two Phase 3 pivotal trials for the treatment of patients with renal cell carcinoma (RCC). “This collaboration underscores our belief in zanzalintinib’s potential to drive patient benefit in combination with immunotherapy or targeted therapy in HNSCC and RCC indications that have unmet clinical need,” said Amy Peterson, M.D., executive vice
https://www.merck.com/news/exelixis-and-merck-sign-clinical-development-collaboration-to-evaluate-investigational-zanzalintinib-in-combination-with-keytruda-pembrolizumab-in-head-and-neck-cancer-and-in-combination-with/
FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI
First and only hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved for these adult patients with advanced RCC This approval of WELIREG marks the first time a new treatment has been approved in a novel therapeutic class in advanced RCC since 2015 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The approval is based on statistically significant and clinically meaningful results from LITESPARK-005, which is the only trial in advanced RCC to specifically evaluate patients who have progressed following a PD-1 or PD-L1 inhibitor and a VEGF-TKI. In the trial, WELIREG
https://www.merck.com/news/fda-approves-mercks-welireg-belzutifan-for-the-treatment-of-patients-with-advanced-renal-cell-carcinoma-rcc-following-a-pd-1-or-pd-l1-inhibitor-and-a-vegf-tki/
Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)
At a pre-specified interim analysis in LITESPARK-005, WELIREG reduced the risk of disease progression or death compared to everolimus First Phase 3 trial to show positive results in patients with advanced RCC following both immune checkpoint and anti-angiogenic therapies in later lines of treatment Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 LITESPARK-005 trial investigating WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies. In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key secondary endpoint of objective response rate (ORR) compared to everolimus. These late-breaking data are
https://www.merck.com/news/mercks-welireg-belzutifan-significantly-improved-progression-free-survival-and-objective-response-rates-versus-everolimus-in-certain-previously-treated-patients-with-advanced-renal-ce/
FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies If approved, WELIREG would provide a new, novel mechanism of action for patients with advanced RCC in need of new options Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental new drug application (sNDA) seeking approval for WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following immune checkpoint and anti-angiogenic therapies. The sNDA is based on data from the LITESPARK-005 trial, in which WELIREG demonstrated a statistically significant and clinically meaningful
https://www.merck.com/news/fda-accepts-for-priority-review-mercks-supplemental-new-drug-application-for-welireg-belzutifan-in-certain-previously-treated-patients-with-advanced-renal-cell-carcinoma-rcc/
Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma
First positive Phase 3 results for WELIREG from LITESPARK-005 showed statistically significant improvements in PFS versus everolimus in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from LITESPARK-005, the first positive Phase 3 trial investigating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. LITESPARK-005 is evaluating WELIREG for the treatment of adult patients with advanced renal cell carcinoma (RCC) that has progressed following PD-1/L1 checkpoint inhibitor and vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) therapies. In the trial, WELIREG showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to everolimus, based on a pre-specified interim analysis conducted by an independent Data Monitoring Committee. A statistically significant improvement in the trial’s key secondary endpoint of objective
https://www.merck.com/news/merck-announces-welireg-belzutifan-phase-3-litespark-005-trial-met-primary-endpoint-of-progression-free-survival-in-certain-previously-treated-patients-with-advanced-renal-cell-carcinoma/
FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
WELIREG Approved for Adult Patients With VHL Disease Who Require Therapy for Associated Renal Cell Carcinoma, Central Nervous System Hemangioblastomas, or Pancreatic Neuroendocrine Tumors, Not Requiring Immediate Surgery WELIREG Expands Merck’s Oncology Portfolio as the First and Only Systemic Therapy Approved for These Patients With VHL Disease Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptable toxicity. The approval is based on results from the
https://www.merck.com/news/fda-approves-mercks-hypoxia-inducible-factor-2-alpha-hif-2%ce%b1-inhibitor-welireg-belzutifan-for-the-treatment-of-patients-with-certain-types-of-von-hippel-lindau-vhl-disease/