The FDA approved Bristol-Myers Squibb's Opdivo for use in adults and in pediatric patients 12 years old and older.
Here's what you should know:
1. The therapy targets microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that continued to progress after receiving fluoropyrimidine, oxaliplatin and irinotecan treatments.
2. The initial approval was made on Opdivo's overall response rate and its response duration. Extended approval will be based on confirmatory trials.
3. In the CheckMate -142 trial, 15 of 53 patients responded to Opdivo after receiving prior treatment with luoropyrimidine, oxaliplatin and irinotecan. Of those 53 patients, one patient had a complete response while 14 had partial responses.
4. Bristol-Myers Squibb U.S. Commercial President Chris Boerner said in a release, "As part of our commitment to address hard-to-treat cancers, with today's approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis."