The FDA has accepted a supplemental Biologics License Application that seeks to extend the use of 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 Aug. 2, 2017.
The submission was based on data from the ongoing phase II CheckMate-142 trial evaluating nivolumab in patients with dMMR or MSI-H metastatic CRC. The efficacy endpoints include investigator-assessed and blinded independent central review committee-assessed objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, duration of response, progression-free survival, and overall survival. Data from this study were presented at the 2017 Gastrointestinal Cancers Symposium in January.
Nivolumab is a PD-1 immune checkpoint inhibitor designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, nivolumab has become an important treatment option across multiple cancers.