Posted by Michael Wonder on 07 Dec 2023
Bristol Myers Squibb's Abecma becomes first CAR T approved for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma in Japan
6 December 2023 - BMS announced today that the company has received manufacturing and marketing approval of the supplemental new drug application for an additional indication for Abecma (idecabtagene vicleucel), a B-cell maturation antigen directed chimeric antigen receptor T cell immunotherapy, for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
The approval is based on the interim analysis from KarMMa-3 (BB2121-MM-003), a global Phase 3 study that evaluated the efficacy and safety of Abecma in patients with relapsed or refractory multiple myeloma who had received two to four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 monoclonal antibody daratumumab.
