FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Priority Review for Bristol-Myers Squibb’s Opdivo in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer

April 12, 2017
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The FDA has granted priority review of the supplemental biologics license application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

The submission was based on data from an ongoing phase 2 trial evaluating Opdivo in patients with dMMR or MSI-H metastatic CRC.

The FDA action date is Aug. 2, 2017.

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