On 8 and 11 April 2025, respectively, BMS announced that the FDA has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment in two new indications:
- 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); and
- for unresectable or metastatic hepatocellular carcinoma.
The FDA granted the BLA for colorectal cancer Breakthrough Therapy Designation and Priority Review status in February this year. Applications for the same combination therapy and indication are under evaluation in Australia and Japan.
The hepatocellular carcinoma indication has been recently approved in Europe (March 2025) and remains under consideration in Australia (October 2024).
On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of BMS’ US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally. Amgen currently has a nivolumab biosimilar under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opdivo®. The study is expected to be completed in 2027.