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

March 27, 2018 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for the combination of nivolumab and ipilimumab 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 sBLA is based on results from a cohort of 119 patients treated with the … (leggi tutto)