Tecartus (brexucabtagene autoleucel)
- Region
- 🇪🇺 EU
- Active substance
- brexucabtagene autoleucel
- Company
- Kite Pharma EU B.V.
- Status
- Authorised
- Therapeutic area
- Lymphoma, Mantle-Cell
- CHMP opinion
- Thu 15 Oct 2020
- EU approval
- Mon 14 Dec 2020
- Designations
- Orphan, PRIME, ATMP, Conditional, Additional monitoring
- Application
- EMEA/H/C/005102
- ATC
- L01X
- Official record
- www.ema.europa.eu
Indication
Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (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.