On 25 January 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product idecabtagene vicleucel (Abecma).
The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
For information, the full indications for Abecma will be as follows (new text in bold):
Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The change in indication is that previously it was indicated in patients who received at least three prior therapies.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation 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.
