FDA Approves Pembrolizumab Combo Therapy for Advanced Renal Cell Carcinoma

Pembrolizumab (Keytruda, Merck) has received FDA approval as a first-line treatment in combination with axitinib (Inlyta) for patients with advanced renal cell carcinoma (RCC), making it the first indication for pembrolizumab in this patient population, according to a press release.

The approval is based on data from the KEYNOTE-426 clinical trial, which evaluated pembrolizumab in combination with axitinib in 861 patients who had not received systemic therapy for advanced RCC.

According to Merck, pembrolizumab is the first anti-PD-1 therapy approved by the FDA as part of a combination regimen that significantly improved OS, PFS, and ORR versus sunitinib in patients with advanced RCC.

A version of this article was originally published by Specialty Pharmacy Times. Visit SpecialityPharmacyTimes.com for the full article.

Reference

FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC) [news release]. Merck. https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-combination-inlyt. Accessed April 22, 2019.