The FDA has granted approval for belzutifan for advanced renal cell carcinoma (RCC) patients who have previously received treatment with 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 regulatory decision was substantiated by findings from the phase 3 LITESPARK-005 study, wherein the co-primary endpoint of progression-free survival (PFS) was achieved.
A descriptive examination of patient-reported symptoms and functional outcomes has indicated enhanced tolerability for belzutifan in comparison to everolimus.
The prescribed dose for belzutifan is 120 mg given orally once daily, to be continued until disease progression or the occurrence of intolerable toxicity.
Dr. Marjorie Green, Senior Vice President and Head of Late-Stage Oncology at Merck Research Laboratories, noted that advanced RCC patients, particularly those progressing after PD-1/L1 and VEGF-TKI treatments, require innovative options to diminish the risk of disease progression or death.
The Phase 3 trial represents a groundbreaking development, showcasing positive outcomes and introducing a novel mechanism for advanced RCC—a significant advancement in recent years. Discussions with health authorities regarding these promising results are eagerly anticipated.
Sources: FDA approves belzutifan for advanced renal cell carcinoma
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma?utm_medium=email&utm_source=govdelivery
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 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/
