EMA Recommends Extension of Therapeutic Indications for Nivolumab and Ipilimumab

Release date: 2025-01-13 11:44:37     Recommended: 422

On November 14, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued favorable opinions, proposing an amendment to the marketing authorization for the drugs nivolumab (Opdivo) and ipilimumab (Yervoy). The marketing authorization for these drugs is held by Bristol-Myers Squibb Pharma EEIG.

The CHMP introduced a new indication, which is highlighted below in bold:

Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)

Opdivo, used in combination with ipilimumab, is indicated for the treatment of adult patients with dMMR or MSI-H colorectal cancer in the following scenarios:

As a first-line treatment for unresectable or metastatic colorectal cancer.

For the treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.Detailed guidelines for the use of these drugs will be outlined in the updated summaries of product characteristics. These summaries will be published in the revised European public assessment reports and made accessible in all official EU languages once the European Commission grants approval for the change in marketing authorization.

Please note that the summaries of positive opinions are published without prejudice to the Commission's final decision, which is typically issued 67 days after the adoption of the opinion.