The approval is supported by data from the phase 3 LITESPARK-011 trial.
Feature|Articles|September 30, 2026
Behind the FDA approval of belzutifan plus lenvatinib in advanced ccRCC, with Robert Motzer, MD
Author(s)Robert J. Motzer, MD, Hannah Clarke
Fact checked by: Benjamin P. Saylor, Strategic Content Lead
Robert J. Motzer, MD, discusses the significance of the belzutifan plus lenvatinib approval, adverse event management with the combination, and the evolving role of HIF-2α inhibition in ccRCC.
Advertisement
Advertisement
The FDA approved belzutifan (Welireg) plus lenvatinib (Lenvima) for adults with advanced renal cell carcinoma (RCC) with a clear cell component following disease progression on a PD-1 or PD-L1 inhibitor in September 2026.1 The decision adds a second-line option with phase 3 superiority data over cabozantinib (Cabometyx) after immunotherapy.
Related to this article
Brian Mazzarella, MD, discusses the landscape for intermediate-risk prostate cancer and early VAPOR 2 findings on water vapor ablation.
The phase 3 BiPASS trial is evaluating the use of 68Ga-PSMA-PET in combination with MRI for pre-biopsy prostate cancer detection.
In RTOG 3506, adding enzalutamide to standard ADT and salvage radiotherapy was associated with 2-year PFS benefit.
Armine K. Smith, MD, discusses the importance of integrating sexual health into bladder cancer care, including proactive counseling, preservation strategies, and multidisciplinary support.
In the phase 3 PACE-A trial, SBRT and prostatectomy showed similar 8-year disease control in localized prostate cancer, with lower rates of urinary incontinence after SBRT.
Using PSMA-PET imaging and genomic testing to obtain better information earlier in the disease course changes what clinicians can do with diagnosis and treatment planning.
The registrational study is designed to evaluate the diagnostic performance of 68Ga-DOTA-RM2 vs histopathology in prostate cancer.
Advertisement
Advertisement