trending Market Intelligence /marketintelligence/en/news-insights/trending/QXeKLseltsOnvCNg_DsSOQ2 content esgSubNav
In This List

US FDA gives priority review to Bristol-Myers' drug combo for kidney cancer

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


US FDA gives priority review to Bristol-Myers' drug combo for kidney cancer

The U.S. Food and Drug Administration accepted Bristol-Myers Squibb Co.'s application for priority review of the company's cancer drug combination to treat a type of kidney cancer.

Bristol-Myers had filed the supplemental biologics license application for priority review of Opdivo plus Yervoy to treat intermediate-and poor-risk patients with advanced renal cell carcinoma.

The application is based on data from the phase 3 CheckMate -214 study, which was stopped early based on the recommendation of an independent data monitoring committee after the drug combination showed superior life expectancy.

Bristol-Myers said the application is expected to be approved by April 16, 2018.

The company said the U.S. FDA previously granted a breakthrough therapy designation for the application, which is the second indication for which the drug combination has received the designation.