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.

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.