Tisagenlecleucel
Tisagenlecleucel (Kymriah, Novartis Europharm Limited) has 3 EU-approved indications in 3 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Acute lymphoblastic leukaemia1 | |||
None | Monotherapy | 2L | B-cell precursor ALL only; Refractory, in relapse post-transplant or in second or later relapse; Up to and including 25 years of age |
| Large B-cell lymphoma1 | |||
None | Monotherapy | 3L+ | DLBCL only; After two or more lines of systemic therapy |
| Follicular lymphoma1 | |||
None | Monotherapy | 3L+ | After two or more lines of systemic therapy |
Full text of section 4.1 (therapeutic indications)
Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Label history
27 changes to the Kymriah label since 2021, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes