FDA accepts application for Opdivo plus Yervoy for MSI-H or dMMR metastatic colorectal cancer for priority review

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Bristol-Myers Squibb Co. said FDA has accepted its supplemental Biologics License Application for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adults with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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For decades, we have faced a central challenge in colorectal cancer screening. One in three eligible Americans—over 50 million people—remain unscreened despite established methods like colonoscopy or stool-based tests existing for decades. This gap persists even though early detection saves lives, and even as colorectal cancer is now the number one cancer killer for Americans under 50.

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