Merck & Co. Inc. (MRK) announced that the U.S. Food and Drug Administration (FDA) has approved its drug belzutifan in combination with lenvatinib for the treatment of advanced renal cell carcinoma (RCC) with clear cell component.
The approval covers adult patients with advanced RCC who have not received prior systemic therapy for advanced disease. The combination is intended for patients with clear cell RCC, a specific type of kidney cancer.
According to the company, the decision was based on data from the phase 3 CLEAR clinical trial. The trial evaluated the safety and efficacy of the combination therapy compared to sunitinib, a standard treatment for the condition.
Merck noted that the FDA approval includes the use of the combination as a first-line treatment for advanced RCC with clear cell component.
