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New Indication Alert: Opdivo® and Yervoy® Combination Approved in Canada for CRC and HCC

Aug 19, 2025

On 19 August 2025, BMS announced that Health Canada has approved an indication extension for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC), and for unresectable or advanced hepatocellular carcinoma (HCC).

This follows recent approvals of the combination therapy for HCC in Taiwan (July 2025), Korea (July 2025), Japan (June 2025), the US (April 2025) and EU (March 2025); and for CRC in the US (April 2025) and Australia (June 2025).

In July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).

At least AmgenSandoz and Xbrane/Intas have nivolumab biosimilars under development.  Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.  In April 2025, Sandoz and Shanghai Henlius Biotech announced a global collaboration agreement for an ipilimumab biosimilar.