BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) 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 (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA granted the application Breakthrough Therapy Designation and Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of 23 June 2025.
The Opdivo®/Yervoy ® combination was approved for these indications in Europe in December 2024, and similar applications are pending elsewhere.
The second quarter of 2025 should also see the result of the FDA’s consideration of the sBLA for the same combination therapy for the treatment of unresectable hepatocellular carcinoma, with a PDUFA goal date of 21 April 2025. Expansion of approval to this indication in Europe was recommended in January 2025.