Kimmtrak (tebentafusp-tebn), a T-cell receptor (TCR) therapy developed by Immunocore, has been approved in the UK, Australia and Canada.
The nods follow US Food and Drug Administration approval in February. The product is approved for the rare eye cancer uveal melanoma.
Analysts expect the therapy to become a new standard of care for this indication, and the company has priced it at $18,760 per vial, or around $400,000 per course in the USA.
In clinical trials, Kimmtrak demonstrated statistically- and clinically-meaningful overall survival (OS) benefit, with median OS of almost 22 months.
A decision from the European Medicines Agency is expected in the third quarter of the year.
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