Obecabtagene autoleucel
Obecabtagene autoleucel (Aucatzyl, Autolus GmbH) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Acute lymphoblastic leukaemia1 | |||
None | Monotherapy | 2L | B-cell precursor ALL only; Relapsed or refractory disease; 26 years of age and above |
Full text of section 4.1 (therapeutic indications)
Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).
Label history
There is no record of changes to the Aucatzyl label that oncolabels can read yet. EMA publishes it some months after the first approval.