European Commission grants final approval for CAR-T treatment idecabtagene vicleucel (Abecma) in earlier lines of therapy for relapsed and refractory myeloma
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The European Commission has granted the final approval for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by Bristol-Myers Squibb (BMS) as Abecma®.
Ide-cel has previously been 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).
This follows an earlier positive recommendation from the EMA – Committee for Medicinal Products for Human Use (CHMP), after which the European Commission had 60 days to ratify.
The 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.
Final approval from the European Commission means that the drug is safe and effective for doctors to prescribe in patients across the EU. However, availability and access within EU countries depends on national funding decisions. MPE will now be working with BMS, our members and other stakeholders to understand how ide-cel will be made available to patients across Europe. If you have any questions, please contact info@mpeurope.org
Further information
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.
For further information on ide-cel, you can read the MPE idecabtagene vicleucel factsheet here.