FDA approves new adjuvant treatment option for ccRCC patients with recurrence risk

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Dana-Farber Cancer Institute Jun 12 2026 The U.S. Food and Drug Administration (FDA) has approved pembrolizumab, an immunotherapy, plus belzutifan, a HIF-2α inhibitor, as adjuvant treatment for adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, with or without resection of metastatic lesions. The approval is based on results from the phase 3 LITESPARK-022 trial, led by Toni Choueiri, MD, director of

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