# Idecabtagene vicleucel

Idecabtagene vicleucel (Abecma, Bristol-Myers Squibb Pharma EEIG) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+ | After at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, with disease progression on the last therapy |

## Products

### Abecma

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: BCMA-directed CAR T-cell therapy
- Class: Antineoplastic agents
- ATC: L01
- EU approval: 18 Aug 2021
- Label revised: 9 Dec 2025
- Status: orphan medicine, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/abecma-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/abecma-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/abecma

Mechanism (SmPC section 5.1): Binds BCMA on plasma cells to trigger CAR T-cell activation, proliferation, cytokine secretion, and cytolytic killing of BCMA-expressing cells.

## Label wording

- **Idecabtagene vicleucel** (Abecma), Multiple myeloma, 3rd line+: “Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/abecma-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/idecabtagene-vicleucel