FDA Approved Keytruda for Kidney Cancer Sooner than Expected

Bristol-Myers Squibb’s Optdivo will face competition two months earlier than anticipated.


When Merck reported that Keytruda (pembrolizumab), in combination with Pfizer’s Inlyta (axitnib), reduced the risk of death in previously untreated kidney cancer patients by nearly 50% compared to Pfizer’s Sutent, Bristol-Myers Squib (BMS) investors became concerned. The U.S. Food and Drug Administration approved the Keytruda/Inlyta combination therapy for patients with previously untreated kidney cancer two months sooner than expected, and analysts are favoring Keytruda in this battle.


This is largely because Keytruda/Inlyta reduced the risk of death by over 40% in patients with and without the PD-L1 biomarker, while the Opdivo/Yervoy combination didn’t achieve those results. In addition, Keytruda/Inlyta was consistently effective across risk groups –– another claim that Optidvo/Yervoy can’t make.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.