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FDA Grants Nivolumab/Ipilimumab Priority Review for MSI-H/dMMR Colorectal Cancer

Jason M. Broderick @jasoncology
Published: Tuesday, Mar 27, 2018

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

The combination, both drugs of which are manufactured by Bristol-Myers Squibb (BMS),  previously received a breakthrough designation in this setting. Under the Prescription Drug User Fee Act, the FDA is scheduled to make its final decision by July 10, 2018. 


“The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy combination to treat patients with previously treated metastatic colorectal cancer defined by MSI-H or dMMR biomarkers, and is a result of our longstanding commitment to the exploration of I-O/I-O combinations for patient populations with high unmet need,” Ian M. Waxman, MD, development lead, Gastrointestinal Cancers, BMS, said in a statement. “We look forward to working with the FDA with the goal of bringing this combination to these colorectal cancer patients.”

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