On 14 November 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending a change to the terms of the marketing authorisation for the medicinal products nivolumab (Opdivo) and ipilimumab (Yervoy). The marketing authorisation holder for these medicinal products is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted a new indication as follows (new indication in bold):
Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)
Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings:
- first-line treatment of unresectable or metastatic colorectal cancer;
- treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
Detailed recommendations for the use of these products will be described in the updated summaries of product characteristics, which will be published in the revised European public assessment reports and made available in all official European Union languages after a decision on this change to the marketing authorisations has been granted by the European Commission
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.