Lifileucel
As of the edition of 20 October 2026, Lifileucel is a cell: marketed, first approved in 2024 (US); US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Cell
- Brand name
- Amtagvi
- First approved
- 16 February 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Iovance Biotherapeutics
- Registered trials
- 33, 6 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Eye
US protection
US protection ends in 2036.
The reference-product exclusivity ends in 2036. The application that gives this date is held by Iovance Biotherapeutics.
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 14 | 1 | 10 | 2 |
| Phase 2 | 17 | 5 | 8 | 4 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Iovance Biotherapeutics | Originator and Lead sponsor of trials | 2023 to now |