Tisagenlecleucel
As of the edition of 20 October 2026, Tisagenlecleucel is a cell: marketed, first approved in 2017 (US); acts on CD19; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Cell
- Brand name
- Kymriah
- First approved
- 30 August 2017 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 45, 10 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Infections; Pregnancy and women's health; Skin and connective tissue
US protection
US protection ends in 2029.
The orphan exclusivity ends in 2029 (it covers one use only). The application that gives this date is held by Novartis.
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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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Tisagenlecleucel.
See the 1 company on route B for this drug, with the facts behind eachRequest 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 | 1 | 0 | 0 | 0 |
| Phase 1 | 13 | 6 | 2 | 3 |
| Phase 2 | 26 | 9 | 7 | 6 |
| Phase 3 | 5 | 1 | 2 | 1 |
| All trials | 45 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2017 to now |