# Ciltacabtagene autoleucel

Ciltacabtagene autoleucel (Carvykti, Janssen-Cilag International NV) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | After at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor; disease progression on the last therapy; refractory to lenalidomide |

## Products

### Carvykti

- Company: Janssen-Cilag International NV
- Target: BCMA-directed CAR T-cell therapy
- Class: Antineoplastic cell and gene therapy
- ATC: L01XL05
- EU approval: 25 May 2022
- Label revised: 29 Oct 2026
- Status: orphan medicine, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/carvykti-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti

Mechanism (SmPC section 5.1): Autologous T cells engineered with a CAR targeting BCMA bind BCMA-expressing cells to promote T-cell activation, expansion, and elimination of target cells.

## Label wording

- **Ciltacabtagene autoleucel** (Carvykti), Multiple myeloma, 2nd line: “CARVYKTI is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/carvykti-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/ciltacabtagene-autoleucel