BMS today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of nivolumab in combination with ipilimumab for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.

The opinion was based on data from the Phase 2 CheckMate -142 trial. The European Commission (EC), which is authorised to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“Metastatic colorectal cancers with mismatch repair deficient or microsatellite instability-high biomarkers can be difficult to treat, and patients who progress on or after first-line chemotherapy still face a great unmet need despite overall progress in the field,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb.

"The CHMP’s positive opinion further supports our goal to advance rational combinations that target distinct but complementary immune pathways. We look forward to the EC’s decision later this year and are excited by the potential positive impact this novel combination could have for patients in need throughout the EU.”

Nivolumab plus ipilimumab received approval from the U.S. Food and Drug Administration (FDA) in July 2018 for the treatment of adult and paediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.

Nivolumab plus ipilimumab was also approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA) in September 2020 for the treatment of MSI-H unresectable, advanced or recurrent colorectal cancer progressing after cancer chemotherapy.

Source: Bristol Myers Squibb