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Merck: FDA Approves KEYTRUDA-Inlyta Combination - Quick Facts

Merck (MRK) announced the U.S. FDA has approved KEYTRUDA in combination with Inlyta for the first-line treatment of patients with advanced renal cell carcinoma. Inlyta (axitinib) is a tyrosine kinase inhibitor.

The approval was based on data from the pre-specified interim analysis of a phase 3 KEYNOTE-426 trial, where KEYTRUDA-axitinib combination reduced the risk of death by nearly half compared to Sunitinib. The KEYNOTE-426 trial also showed significant improvements in overall survival, progression-free survival and objective response rate for the KEYTRUDA-axitinib combination compared to sunitini.

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