Kimmtrak (tebentafusp)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tebentafusp
- Company
- Immunocore Ireland Limited
- Status
- Authorised
- Therapeutic area
- Uveal Neoplasms
- CHMP opinion
- Thu 27 Jan 2022
- EU approval
- Fri 01 Apr 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/004929
- ATC
- L01XX75
- Official record
- www.ema.europa.eu
Indication
Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.