On 25 August 2025, Ono Pharma and Bristol-Myers Squibb announced that they received supplemental approval in Japan for Opdivo® (nivolumab) and Yervoy® (ipilimumab) in combination therapy for the treatment of unresectable advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer (CRC). The approval comes nearly a year after the companies submitted the application to Japan’s Ministry of Health, Labour and Welfare.
The Opidvo®/Yervoy® combination has previously been approved for the same indication in Canada (August 2025), Australia (June 2025), the US (April 2025) and EU (December 2024), and was recommended for NHS funding in the UK (April 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 Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.