Skip to main content

Abecma FDA Approval History

Last updated by Judith Stewart, BPharm on June 30, 2025.

FDA Approved: Yes (First approved March 26, 2021)
Brand name: Abecma
Generic name: idecabtagene vicleucel
Dosage form: Suspension for Intravenous Infusion
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Myeloma

Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Development timeline for Abecma

DateArticle
Jun 26, 2025Approval U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels for Breyanzi and Abecma
Apr  5, 2024Approval U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
Mar 26, 2021Approval FDA Approves Abecma (idecabtagene vicleucel) as the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
Sep 22, 2020U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
Jul 29, 2020Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma
May 13, 2020Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma
Mar 31, 2020Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) to FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.