Tabelecleucel
Tabelecleucel (Ebvallo, Pierre Fabre Medicament) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: EBV (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Post-transplant lymphoproliferative disorder1 | |||
EBV-positive | Monotherapy | 2L | After at least one prior therapy (for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate); Aged 2 years and older |
Full text of section 4.1 (therapeutic indications)
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.
Label history
8 changes to the Ebvallo label since 2023, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes