Posted by Michael Wonder on 12 Jun 2026
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
12 June 2026 - Today, the FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Efficacy was evaluated in LITESPARK-022, a multicenter, double-blind, randomized trial in 1,841 patients with prior nephrectomy for clearc cell renal cell carcinoma who were at intermediate high or high risk of recurrence, or who had resected metastases with no evidence of disease.
