Tebentafusp-Tebn

Treats HLA-A*02. Sold as Kimmtrak. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Tebentafusp-Tebn (sold as Kimmtrak), first approved Jan 25, 2022, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 25, 2022
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $95.3M
Orphan exclusivity until: Jan 25, 2029
First approved in the EU: Apr 1, 2022

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Kimmtrak	Part B	$95.3M	+9%	189

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of uveal melanomaImmunocore Ltd · designated Jan 21, 2016 · approved Jan 25, 2022 · exclusive to Jan 25, 2029

Approvals in the EU (EMA)

First approved in the EU 2 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Kimmtrak, new substanceImmunocore Ireland Limited · Apr 1, 2022

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Tebentafusp-tebn With LDT in Metastatic UMMetastatic Uveal Melanoma · Thomas Jefferson University	Phase 1 / Phase 2	Recruiting	Oct 4, 2024
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal MelanomaMetastatic Uveal Melanoma, Metastatic Uveal Melanoma in the Liver · University of Miami	Phase 2	Recruiting	Oct 4, 2024
Neoadjuvant Tebentafusp for Uveal MelanomaLocally Advanced Unresectable Uveal Melanoma · Thomas Jefferson University	Phase 2	Recruiting	May 16, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jan 25, 2022	KimmtrakBLA 761228 · New molecular entity	Immunocore Ltd	2	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA