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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Renal Cell Carcinoma |
| Drug: | Welireg (belzutifan) (HIF-2α inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
12/14/2023
Excerpt:
Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for 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).
Source:
Published date:
06/17/2022
Excerpt:
Subsequent Therapy for Clear Cell Histology...Useful in Certain Circumstances...Belzutifan was added as a category 2B recommendation.
Source:
Title:
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).
Published date:
09/19/2023
Excerpt:
Merck...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.
Source:
Title:
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
Published date:
08/18/2023
Excerpt:
Merck...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 response rate (ORR) was also demonstrated.
Trial ID:
Source:
Title:
Merck Receives Priority Review From FDA for New Drug Application for HIF-2a Inhibitor Belzutifan (MK-6482)
Published date:
03/16/2021
Excerpt:
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan (pronounced bell-ZOO-ti-fan), a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC)...
Source:
Title:
FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2a Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma
Published date:
07/29/2020
Excerpt:
...Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC)with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.
