Opdivo + Yervoy filed sBLA at FDA to treat microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer . - BMS.

Bristol-Myers Squibb Company announced that the FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The FDA granted the application priority review and, in February 2018, granted the combination Breakthrough Therapy Designation for this potential indication, recognizing the need for new treatment approaches in this patient population. The FDA action date is July 10, 2018.

This application is based on data from the ongoing Phase II CheckMate -142 study evaluating the Opdivo and Yervoy combination in previously treated patients with MSI-H or dMMR mCRC. Data from this study were presented in January at the 2018 Gastrointestinal Cancers Symposium and published simultaneously in the Journal of Clinical Oncology.

See- "Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair�Deficient/Microsatellite Instability�High Metastatic Colorectal Cancer"- Michael J. Overman, Sara Lonardi, Ka Yeung Mark Wong, Heinz-Josef Lenz, Fabio Gelsomino, Massimo Aglietta,et.,al. ..DOI: 10.1200/JCO.2017.76.9901 Journal of Clinical Oncology 36, no. 8 (March 2018) 773-779. PMID: 29355075.