The FDA granted New York City-based Bristol-Myers Squibb's biologics license application for Opdivo priority review status.
Here's what you should know.
1. The drug maker is seeking additional approval to extend Opdivo's uses to include "patients with mismatch repair deficient or microsatellite instability high metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy," according to a release.
2. The FDA's action date is Aug. 2.
3. Bristol-Myers Squibb's Development Lead for Gastrointestinal Oncology Products Ian M. Waxman, MD, said the drug maker wants to provide metastatic colorectal cancer with patients with mismatch repair deficient or MSI-H biomarkers patients a new treatment option.
He said in a release, "These patients have a distinct unmet need, as they are less likely to benefit from conventional chemotherapy and have a shorter overall survival than patients with metastatic colorectal cancer without these biomarkers.