On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with unresectable or advanced hepatocellular carcinoma (HCC). The EC approval follows the CHMP’s positive opinion for the expanded indication in January 2025.
The same indication for the Opdivo®/Yervoy® combination is currently under review by the FDA, with BMS’ sBLA accepted in August 2024. The FDA assigned a PDUFA goal date of 21 April 2025.
In December 2024, the European Commission approved Opdivo®/Yervoy® for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). Applications for this indication are also pending in countries including the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).