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aBLA Filing Intelligence & Biosimilar Opportunity

Kimmtrak

Tebentafusp-Tebn
Anticancer
Injection Injectable

Metastatic uveal melanoma responds poorly to checkpoint inhibitors, and no therapy had ever demonstrated a survival benefit. Kimmtrak (tebentafusp) was the first to do so.

It uses an engineered T-cell receptor recognizing gp100 on melanoma cells, fused to an anti-CD3 domain that physically recruits T cells to kill them. The weekly intravenous infusion treats HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

Kimmtrak requires HLA genotyping, which restricts eligibility to roughly half of patients, and initial dosing must occur in hospital because of cytokine release risk. As the first approved ImmTAC, it is the platform-validating asset for the broader TCR bispecific field.

Approval Date
25-Jan-22
Data Exclusivity Expiry
25-Jan-26
Market Exclusivity Expiry
25-Jan-34
Commercial snapshot

Market performance & projections

Revenue ($M)
401
CAGR (%)
11.46%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
443
2027
495
2028
543
2029
619
2030
696
2031
722
2032
795
Molecule profile

Details & specifications

Molecule
Tebentafusp-Tebn
Innovator
IMMUNOCORE COMMERCIAL LLC
Dosage Form
Injection Injectable
Strength
100 mcg/0.5 mL
Therapeutic Category
Anticancer
Usage
To treat unresectable or metastatic uveal melanoma
Good to know

Frequently asked questions

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