Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated superior progression-free survival compared to Opdivo monotherapy and investigator’s choice of chemotherapy.
BMS today announced that the US FDA has accepted the supplemental biologics license application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and paediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
