Idecabtagene vicleucel
| Gene therapy | |
|---|---|
| Target gene | TNFRSF17 |
| Clinical data | |
| Trade names | Abecma |
| Other names | bb2121, ide-cel |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a621024 |
| License data | |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| UNII | |
| KEGG | |
Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma.[2][6][7]
The most common side effects include cytokine release syndrome (CRS), infections, fatigue, musculoskeletal pain, and a weakened immune system (hypogammaglobulinemia).[3][6]
Idecabtagene vicleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.[3][6] 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.[3][6]
Idecabtagene vicleucel was approved for medical use in the United States in March 2021.[3][6] It is the first cell-based gene therapy approved by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma.[3][6] It was approved for medical use in the European Union in August 2021.[4][8]
- ^ "Summary Basis of Decision (SBD) for Abecma". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ a b "Abecma- idecabtagene vicleucel suspension". DailyMed. 29 July 2024. Retrieved 20 September 2024.
- ^ a b c d e f "Abecma". U.S. Food and Drug Administration (FDA). 27 March 2021. Archived from the original on 9 December 2023. Retrieved 29 March 2021. This article incorporates text from this source, which is in the public domain.
- ^ a b "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.
- ^ a b c d e f "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.
- ^ "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.