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Bristol-Myers: Opdivo + Low-Dose Yervoy Approved For MSI-H/dMMR MCRC Patients

Bristol-Myers Squibb Company (BMY) announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

The company noted that the approval for the indication has been granted under accelerated approval based on overall response rate and duration of response. Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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