tecelra Purple Book BLA 125789
- BLA number
- 125789
- Proprietary names
- tecelra
- Proper names
- afamitresgene autoleucel
- Applicant
- USWM CT, LLC
- Center
- CBER
- First observed release
- 2024-08-01
- Latest observed release
- 2026-08-01
- Newest archive release
- 2026-08-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | tecelra | afamitresgene autoleucel | 351(a) | 2.68 x 10^9 to 10 x 10^9 CELL/ML | Suspension | Intravenous | Bag | Rx | Licensed | 2024-08-01 | |
| 002 | tecelra | afamitresgene autoleucel | 351(a) | 1.62 x 10^9 to 10 x 10^9 CELL/ML | Suspension | Intravenous | Bag | Rx | Licensed | 2026-06-17 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-08-01 | N | 002 | tecelra | 351(a) | Rx | USWM CT, LLC |
| 2026-01-01 | U | 001 | tecelra | 351(a) | Rx | USWM CT, LLC |
| 2024-09-01 | U | 001 | tecelra | 351(a) | Rx | Adaptimmune LLC |
| 2024-08-01 | N | 001 | tecelra | 351(a) | Rx | Adaptimmune LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-08-01 | 002 | tecelra | 351(a) | Rx | Licensed | 2026-06-17 |
| 2024-08-01 | 001 | tecelra | 351(a) | Rx | Licensed | 2024-08-01 |