Post-transplant lymphoproliferative disorder

The EU has approved 1 indication of 1 drug in post-transplant lymphoproliferative disorder. It needs a biomarker result: EBV (1).

Line of therapy

Approved indications, Post-transplant lymphoproliferative disorder
DrugBiomarker requirementRegimenSettingConditions
EBV1
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

Biomarkers in post-transplant lymphoproliferative disorder

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Tabelecleucel (Ebvallo)
    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.