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Abecma FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2021.

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 chimeric antigen receptor (CAR) T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

  • Abecma is a customized treatment created by using a patient’s own T-cells, which are collected and genetically modified to recognize and attack multiple myeloma cells. Once modified, the cells are infused back into the patient.
  • Abecma is administered as an intravenous infusion two days after pretreatment with a 3-day lymphodepleting chemotherapy regimen. Abecma must be administered at a REMS-certified healthcare facility and patients need to remain within proximity of the facility for at least 4 weeks following infusion.
  • Abecma treatment may cause serious adverse reactions. The Abecma product label carries a boxed warning for cytokine release syndrome (CRS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), neurologic toxicity, and prolonged cytopenia, all of which can be fatal or life-threatening.
  • Common nonlaboratory adverse reactions include CRS, infections, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite. Common laboratory adverse reactions include neutropenia, leukopenia, lymphopenia, thrombocytopenia, and anemia.

Development Timeline for Abecma

DateArticle
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

See Also

Abecma (idecabtagene vicleucel) Consumer Information

Further information

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