New Indication Alert: BMS’s Abecma® (idecabtagene vicleucel) Receives EU Approval For Extended Indication

On 20 March, 2024, BMS announced that its CAR-T cell immunotherapy Abecma ® (idecabtagene vicleucel) was granted an extension of its therapeutic indication, now being approved for treatment of relapsed and refractory multiple myeloma (R/R MM) in patients undergoing their third line of treatment (the indication was previously limited to fourth line treatment). The approval of the amended indication by European Commission follows an earlier positive recommendation from the EMA – Committee for Medicinal Products for Human Use (CHMP). The approval positions Abecma® as the first CAR-T cell therapy approved in the European Union for adult patients with R/R MM undergoing their third line of treatment.