Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma.[4][8]
The most common side effects include cytokine release syndrome (CRS), infections, fatigue, musculoskeletal pain, and a weakened immune system (hypogammaglobulinemia).[4][5]
Idecabtagene vicleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.[4][5] Each dose is customized using a patient's own T-cells, which are a type of white blood cell, that are collected and genetically modified to include a new gene that facilitates targeting and killing myeloma cells, and infused back into the patient.[4][5]
Idecabtagene vicleucel was approved for medical use in the United States in March 2021.[3][4][5] It is the first cell-based gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.[4][5] It was approved for medical use in the European Union in August 2021.[6][9]
^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
^"Summary Basis of Decision (SBD) for Abecma". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
^ ab"Abecma". U.S. Food and Drug Administration (FDA). 27 March 2021. Archived from the original on 9 December 2023. Retrieved 29 March 2021.
^ abcdefg"FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma". U.S. Food and Drug Administration (FDA) (Press release). 27 March 2021. Archived from the original on 28 March 2021. Retrieved 29 March 2021. This article incorporates text from this source, which is in the public domain.
^ abcdefCite error: The named reference FDA Idecabtagene vicleucel was invoked but never defined (see the help page).
^ ab"Abecma EPAR". European Medicines Agency (EMA). 23 June 2021. Archived from the original on 26 August 2021. Retrieved 26 August 2021.
^"Abecma Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
^"U.S. Food and Drug Administration Approves Bristol Myers Squibb's and bluebird bio's Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma" (Press release). Bristol Myers Squibb. 26 March 2021. Archived from the original on 29 March 2021. Retrieved 29 March 2021 – via Business Wire.
^"Abecma". Union Register of medicinal products. 19 August 2021. Archived from the original on 1 October 2023. Retrieved 1 October 2023.
and 29 Related for: Idecabtagene vicleucel information
Idecabtagenevicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma. The most common side effects include...
two immunomodulatory agents and an anti-CD38 monoclonal antibody idecabtagenevicleucel: first cell-based gene therapy was approved by FDA in 2021 for the...
Center for Biologics Evaluation and Research (2021-03-27). "ABECMA (idecabtagenevicleucel)". FDA. European Medicines Agency (2023-07-27). "Abecma". EMA. Center...
BMS and bluebird bio's marketing application seeking approval of idecabtagenevicleucel (ide-cel) for patients with heavily pre-treated relapsed and refractory...
Global Information
This article incorporates text from this source, which is in the public domain.
