Bristol Myers Squibb (BMY)

[chmcnfunds]

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer

Application based on results from Phase 2 CheckMate -142 study

April 04, 2017 04:15 PM Eastern Daylight Time

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted a 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 FDA granted the application priority review, and the FDA action date is August 2, 2017.

http://www.businesswire.com/news/home/20170404006413/en/U.S.-Food-Drug-Administration-Accepts-Priority-Review

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