Breyanzi Purple Book BLA 125714
- BLA number
- 125714
- Proprietary names
- Breyanzi
- Proper names
- lisocabtagene maraleucel
- Applicant
- Juno Therapeutics, Inc. a Bristol Myer-Squibb Company
- Center
- CBER
- First observed release
- 2021-02-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- 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 | Breyanzi | lisocabtagene maraleucel | 351(a) | 4.6ML/VIAL | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2021-02-05 | |
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 |
|---|
| 2024-07-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, Inc. a Bristol Myer-Squibb Company |
| 2024-06-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, Inc. a Bristol Myer-Squibb Company |
| 2024-04-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, Inc. a Bristol Myer-Squibb Company |
| 2023-03-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, Inc. a Bristol Myer-Squibb Company |
| 2022-01-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, Inc. a Bristol Myer-Squibb Company |
| 2021-10-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, Inc., a Bristol Myer-Squibb Company |
| 2021-09-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, a Celgene Company |
| 2021-05-01 | U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, a Celgene Company |
| 2021-02-01 | N, U | 001 | Breyanzi | 351(a) | Rx | Juno Therapeutics, a Celgene Company |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2021-02-01 | 001 | Breyanzi | 351(a) | Rx | Licensed | 2021-02-05 |