FDA accepts sBLA to extend the use of Opdivo (nivolumab) to patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC).- BMS

Bristol-Myers Squibb Company announced that the 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 2 August 2017. The submission was based on data from the ongoing Phase II CheckMate -142 trial evaluating Opdivo 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 (ORR) 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.

Comment: Microsatellite instability is a biomarker in certain kinds of cancer and is caused when a cell is not able to repair DNA sequencing errors (mismatch repairs), leading to more errors in microsatellite repeats after the cells divide. MSI-H is seen in around 15% of patients with colorectal cancer.

Comment; Merck Inc. has in November 2016 filed a sBLA at the FDA for Keytruda to treat microsatellite instability high (MSI-H) metastatic colorectal cancer and has a PDUFA date of 9 June 2017.