Ciltacabtagene autoleucel
As of the edition of 20 October 2026, Ciltacabtagene autoleucel is a gene: marketed, first approved in 2022 (US); acts on TNFRSF17; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Gene
- Brand name
- Carvykti
- First approved
- 28 February 2022 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Johnson & Johnson; 3 holders in all
- Registered trials
- 19, 1 stopped early
- Disease areas
- Blood and lymph; Cancer; Heart and blood vessels; Immune system; Infections; Nutrition and metabolism
US protection
US protection ends in 2034.
The reference-product exclusivity ends in 2034. The application that gives this date is held by Johnson & Johnson.
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.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| TNFRSF17 | Tumor necrosis factor receptor superfamily member 17 | Q02223 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 1 | 0 |
| Phase 1 | 3 | 0 | 3 | 0 |
| Phase 2 | 9 | 2 | 6 | 1 |
| Phase 3 | 3 | 0 | 3 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2021 to now |