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Immunocore gets FDA breakthrough nod for eye melanoma drug ahead of planned Q3 filing

February 19, 2021

Immunocore has received FDA breakthrough-therapy designation for tebentafusp in unresectable or metastatic uveal melanoma. The British biotech snagged the status ahead of a planned filing for FDA approval in the third quarter.

Tebentafusp is a bispecific TCR molecule designed to target an HLA-A*02:01 gp100 antigen and recruit, engage and activate T cells. A phase 3 trial in patients with previously untreated metastatic uveal melanoma linked the drug to improved overall survival at the first preplanned interim analysis, causing the study to hit its primary endpoint with a hazard ratio of 0.51.

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