Brexucabtagene autoleucel
As of the edition of 20 October 2026, Brexucabtagene autoleucel is a gene: marketed, first approved in 2020 (US); acts on CD19; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Gene
- Brand name
- Tecartus
- First approved
- 24 July 2020 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Gilead Sciences; 2 holders in all
- Registered trials
- 16, 2 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Infections; Heart and blood vessels
US protection
US protection ends in 2032.
US protection ends in 2032, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Gilead Sciences. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CD19 | B-lymphocyte antigen CD19 | P15391 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 1 | 0 |
| Phase 1 | 2 | 0 | 1 | 1 |
| Phase 2 | 11 | 4 | 6 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Originator, Applicant and Lead sponsor of trials | 2020 to now |