Brexucabtagene Autoleucel
Antineoplastic Cell and Gene Therapy
Sold as TECARTUS
- Drug class
- Antineoplastic Cell and Gene Therapy
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 4
Overview
Brexucabtagene Autoleucel is an active pharmaceutical ingredient in the Antineoplastic Cell and Gene Therapy group (L01XL). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 2 | January 8, 2026 |
| EU European Union | EMA | 1 | May 19, 2026 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
CACanada· Health Canada
2 products
Uses
TECARTUS (brexucabtagene autoleucel suspension for intravenous infusion) is a CD19-directed genetically modified autologous T-cell immunotherapy 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.
• the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1 Pediatrics The safety and efficacy of TECARTUS in patients < 18 years of age have not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics In MCL, evidence from clinical studies suggest that efficacy and safety in patients ≥ 65 years of age were consistent with the overall treated patient population. In ALL, evidence from clinical studies is not sufficient to determine if the use of TECARTUS in patients ≥ 65 years of age is associated with differences in safety and effectiveness.
EUEuropean Union· EMA
1 product
Uses
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).
How to take
GBUnited Kingdom· MHRA
1 product
Uses
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).
How to take
Drug interactions
Known interactions involving Brexucabtagene Autoleucel. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02516667 · revised January 8, 2026
- [2]European Medicines Agency · EMEA/H/C/005102 · revised May 19, 2026
- [3]MHRA (UK) · PLGB119720045 · revised May 15, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.