The FDA approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda)—or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)—for 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 metastatic lesion resection. Approval was based on results from the LITESPARK-022 trial, in which the combination reduced the risk of disease recurrence or death by 28% compared with pembrolizumab plus placebo as adjuvant therapy. The FDA granted this approval on June 12, 2026, giving patients at higher risk of kidney cancer recurrence an additional adjuvant treatment option after surgery. Sources: KEYTRUDA® (pembrolizumab) Plus WELIREG® (belzutifan) Given ... FDA approves belzutifan with pembrolizumab for adjuvant treatment ... FDA Approves Merck's KEYTRUDA® (pembrolizumab) as Adjuvant ... The FDA has approved Welireg + Keytruda for ad...
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