Tebentafusp
Also known as Kimmtrak, Tebentafusp-tebn
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
BLA761228,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Immunocore Holdings plc IMCR Source: Company record for Immunocore Holdings plc (opens in a new tab)
- Indication
- Advanced Melanoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 761228 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761228 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 19 Dec 20221 linked trial
- Filed Completed
- Approved Current stageFirst approval 25 Jan 2022
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Tebentafusp. Editors add each one with its source.
Filed application
No filed application is on record for Tebentafusp. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Tebentafusp.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05549297ClinicalTrials.gov record for NCT05549297 (opens in a new tab) | Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) | Phase 3 | Recruiting | 540 (estimated) | Mar 2028 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA761228Action letter for BLA761228 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedOrphan medicine
Kimmtrak (EMEA/H/C/004929)
- Authorised
- Therapeutic area
- Uveal Neoplasms
- Marketing authorisation holder
- Immunocore Ireland Limited
- Active substance (INN)
- tebentafusp
- ATC code
- L01XX75
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Kimmtrak (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 761228 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05549297 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA761228 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.