The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has given a positive recommendation for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by BMS as Abecma®.

Ide-cel is currently approved for the treatment of patients with relapsed and refractory myeloma, who have received at least three previous lines of therapy. The extension means that ide-cel will now be indicated for the treatment of patients with relapsed and refractory myeloma who have undergone at least two prior therapies, including an immunomodulatory agent (IMiD – such as lenalidomide and pomalidomide), a proteasome inhibitor (PI – such as bortezomib and carfilzomib) and an anti-CD38 monoclonal antibody (such as daratumumab and isatuximab).

The CHMP decision is based on the final analysis of progression-free survival (PFS – the length of time before myeloma progresses) in the Phase 3 KarMMa-3 clinical trial. Results, presented at the December 2023 American Society of Hematology (ASH) Annual Meeting, found that ide-cel improved PFS compared to standard regimens.

The European Commission now has 60 days in which to consider and adopt the CHMP commission recommendation. Commission approval would make ide-cel the first myeloma CAR T-cell therapy in Europe with marketing authorisation for earlier stages of the disease. However, for patients to receive ide-cel, there first needs to be funding approval by national healthcare authorities.

Further information

For further information on ide-cel, you can read the MPE idecabtagene vicleucel factsheet here.

MPE interviewed Prof. Dr. Michel Delforge of the Department of Haematology at the University Hospital Leuven, at the ASH 2023 meeting about the Phase 3 KarMMa-3 study findings and quality of life. You can watch the video interview here.

If you have any questions or comments about the CHMP decision, please email info@mpeurope.org