US FDA Approves New Combination Therapy for Advanced Kidney Cancer

The U.S. Food and Drug Administration (FDA) has approved a new combination treatment for certain adult patients with advanced kidney cancer whose disease has progressed after immunotherapy. The approved regimen combines the drugs belzutifan and lenvatinib for patients with advanced clear cell renal cell carcinoma who have previously received anti-PD-1 or anti-PD-L1 immunotherapy.

The approval, granted on September 24, is based on a clinical trial involving 747 patients. In the study, the combination of belzutifan and lenvatinib extended the median time without disease progression by approximately four months compared to the control treatment, cabozantinib. The median progression-free survival was 14.6 months for the combination group versus 10.6 months for the control group.

While the combination showed a higher objective response rate, with 53% of patients experiencing tumor shrinkage or disappearance compared to 40% in the control group, the study did not demonstrate a statistically significant improvement in overall survival. This distinction is important, as the treatment delays disease progression but has not been proven to extend life.

The FDA has issued warnings associated with the drugs, including anemia and decreased blood oxygen levels for belzutifan. When combined with lenvatinib, additional concerns include cardiac dysfunction and potential kidney impairment, as well as high blood pressure. Treatment decisions will require careful consideration of the patient's condition, medical history, prior treatments, and monitoring for side effects.

This U.S. approval expands treatment options for a specific group of advanced kidney cancer patients. The availability and status of this combination therapy in Israel require separate investigation.