Merck Wins FDA Approvals for Keytruda Combination in Kidney Cancer

By Doc Louallen

Merck & Co. said the U.S. Food and Drug Administration approved two Keytruda-based combinations for certain patients with kidney cancer after surgery.

The FDA cleared Keytruda and Keytruda QLEX, each used with Merck's pill Welireg. The approvals cover adults with clear cell renal cell carcinoma at intermediate-high or high risk of the disease returning after nephrectomy. They also apply after nephrectomy and removal of metastatic lesions.

The approvals are based on a Phase 3 study that showed the Keytruda-Welireg combo cut the risk of the cancer coming back, spreading or death by 28% compared with Keytruda plus placebo. The trial, called LITESPARK‑022, enrolled 1,841 patients.

The study hasn't followed patients long enough to show whether the treatment helps people live longer.

Merck said these are the first approved combinations of a PD-1 drug and an HIF-2 inhibitor. It is also the first global Phase 3 study to show improved disease-free survival over Keytruda alone. The treatments are used as adjuvant therapy. That is medicine given after surgery to lower the chance the cancer returns.

Write to Doc Louallen at doc.louallen@wsj.com

(END) Dow Jones Newswires

June 12, 2026 17:21 ET (21:21 GMT)