Opdivo sBLA accepted for priority review in dMMR or MSI-H metastatic colorectal cancer

The US Food and Drug Administration has accepted a supplemental Biologics License Application (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) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

The agency granted the application priority review for the drug from US pharma major Bristol-Myers Squibb (NYSE: BMY), and the FDA action date is August 2, 2017.

Opdivo has already received approval to treat advanced melanoma, a type of lung cancer, kidney cancer, and Hodgkin lymphoma from the FDA and other regulatory agencies. Sales of the drug in 2016 were up massively on 2015, soaring from $942 million to $3.77 billion, making it the company’s top-selling product.