Axicabtagene ciloleucel
Axicabtagene ciloleucel (Yescarta, Kite Pharma EU B.V.) has 3 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Large B-cell lymphoma2 | |||
None | Monotherapy | 2L | DLBCL or HGBL only; First-line chemoimmunotherapy (relapsed within 12 months from completion or refractory) |
None | Monotherapy | 3L+ | DLBCL or PMBCL only; After two or more lines of systemic therapy |
| Follicular lymphoma1 | |||
None | Monotherapy | 3L+ | After three or more lines of systemic therapy |
Full text of section 4.1 (therapeutic indications)
Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.
Label history
26 changes to the Yescarta label since 2019, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes