Aucatzyl (obecabtagene autoleucel)
PRIMEATMPConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- obecabtagene autoleucel
- Company
- Autolus GmbH
- Status
- Authorised
- Therapeutic area
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Thu 17 Jul 2025
- Designations
- PRIME, ATMP, Conditional, Additional monitoring
- Application
- EMEA/H/C/005907
- ATC
- L01XL
- Official record
- www.ema.europa.eu
Indication
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.