New indication for Opdivo helps repair damage from AZ trial failure fallout
New York-based Bristol-Myers Squibb (NYSE: BMY) has received approval from the US Food and Drug Administration for Opdivo (nivolumab) in a new indication.
The immunotherapy may now be marketed as a treatment for adult and pediatric patients with certain kinds of colorectal cancer that have progressed despite treatment.
The approval was given under the agency’s accelerated approval based on clinical data from the CheckMate trial, related to overall response rate and duration of response. Continued approval may depend on confirmatory trials.
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