# Tabelecleucel

Tabelecleucel (Ebvallo, Pierre Fabre Medicament) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: EBV (1).

## Approved indications

### Post-transplant lymphoproliferative disorder

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EBV-positive | Monotherapy | 2nd line | After at least one prior therapy (for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate); Aged 2 years and older |

## Products

### Ebvallo

- Company: Pierre Fabre Medicament
- Target: Allogeneic EBV-specific T-cell immunotherapy
- EU approval: 16 Dec 2022
- Label revised: 2 Oct 2026
- Status: exceptional circumstances, orphan medicine, PRIME, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ebvallo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ebvallo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ebvallo

Mechanism (SmPC section 5.1): Allogeneic T cells whose receptors recognise EBV peptides presented by specific HLA molecules on target cells, killing EBV-infected cells in an HLA-restricted manner.

## Label wording

- **Tabelecleucel** (Ebvallo), Post-transplant lymphoproliferative disorder, 2nd line: “Ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ebvallo-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/tabelecleucel