Breakthrough for advanced kidney cancer patients: Innovative treatment approved in the US

The US Food and Drug Administration (FDA) has approved a new drug combination (belzutifan and lenvatinib) for patients with advanced clear cell renal cell carcinoma, following immunotherapy. The approval was based on a study of 747 patients, in which the combination extended median progression-free survival by four months compared to the control treatment. However, a significant overall survival benefit was not demonstrated.

On September 24, the US Food and Drug Administration (FDA) approved a new treatment for patients with advanced kidney cancer. The treatment is a combination of the drugs belzutifan and lenvatinib, intended for adults with clear cell renal cell carcinoma whose disease has progressed after immunotherapy. The approval was based on a clinical trial involving 747 patients. In the group receiving the combination, median progression-free survival was 14.6 months, compared to 10.6 months in the control group receiving cabozantinib – a difference of about four months. The response rate (tumor shrinkage or disappearance) was 53% in the combination group versus 40% in the control group. However, the final analysis did not demonstrate a statistically significant difference in overall survival between the groups. The FDA lists warnings including anemia, decreased blood oxygen levels, impaired heart function, high blood pressure, and potential kidney impairment. The approval is valid only in the United States; its status in Israel has yet to be determined.