FDA clears belzutifan for two renal cell carcinoma uses, plus updated pembrolizumab label
The agency approved belzutifan paired with lenvatinib for advanced clear cell renal carcinoma and separately with pembrolizumab regimens as adjuvant therapy, while also updating pembrolizumab's label for TMB-H solid.
The FDA approved belzutifan, sold by Merck & Co., Inc. as Welireg, in combination with Eisai Inc.'s lenvatinib (Lenvima) on September 24, 2026, for adults with advanced renal cell carcinoma that includes a clear cell component. The approval covers adults with advanced renal cell carcinoma with a clear cell component, using belzutifan alongside lenvatinib.1
Separately, the agency had earlier approved belzutifan for use after surgery in kidney cancer patients. On June 12, 2026, the FDA approved belzutifan combined with either pembrolizumab or with pembrolizumab and berahyaluronidase alfa-pmph, marketed as Keytruda Qlex, for adjuvant treatment of adults with renal cell carcinoma.2 Both pembrolizumab formulations are products of Merck & Co., Inc.
In a related action on pembrolizumab, the FDA granted traditional approval covering use of pembrolizumab alone or combined with berahyaluronidase alfa-pmph for patients with unresectable or metastatic tumors bearing high tumor mutational burden (TMB-H). The agency described this as an oncology update converting the TMB-H solid tumor indication to traditional approval and reflecting an updated indication for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph.3
The documents released by the FDA do not specify the clinical trial data, dosing schedules, or prior accelerated approval status that may have supported these decisions. No further regulatory or commercial milestones were disclosed in the available records as of November 6, 2026.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.