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# FDA OKs Keytruda Plus Inlyta for Kidney Cancer
- URL: https://www.fdaweb.com/fda-oks-keytruda-plus-inlyta-for-kidney-cancer/
- Published: 2019-04-22T12:00:00.000Z
- Updated: 2026-09-15T01:21:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143922

FDA has approved a Merck supplemental NDA for use of its Keytruda (pembrolizumab) plus axitinib (Pfizer’s Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on data from the KEYNOTE‑426 (NCT02853331), an 861-patient trial in those who had not received systemic therapy for advanced RCC. The trial demonstrated a statistically significant improvement in overall survival (OS) in a pre-specified interim analysis for patients on the pembrolizumab plus axitinib compared with those on an active comparator.

An [FDA release](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm636395.htm?ref=fdaweb.com) says that with “deaths reported in 18% of patients, the median OS was not reached in either arm.” The 12-month OS rate was 90% in the pembrolizumab plus axitinib arm and 78% for those treated with sunitinib (Pfizer’s Sutent). The trial also demonstrated a progression-free survival (PFS) improvement for patients receiving pembrolizumab plus axitinib. “Median PFS was 15.1 and 11.1 months for those receiving pembrolizumab plus axitinib vs. sunitinib, respectively,” it says.