TEBENTAFUSP

FDA Drug Profile — KIMMTRAK

Drug Details

Generic Name
TEBENTAFUSP
Brand Names
KIMMTRAK
Application Number
BLA761228
Sponsor
Immunocore Commercial LLC
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
TEBENTAFUSP

Indications and Usage

1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).