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ARTICLE | Regulation

Immunocore charts path to broader indications, new targets after first FDA approval

Kimmtrak authorization brings the first uveal melanoma therapy and a new immuno-oncology modality to market

January 27, 2022 1:20 AM UTC

FDA’s approval of Immunocore’s Kimmtrak tabentafusp for uveal melanoma kicks off what could be a transformational year in immuno-oncology drug approvals, and sets the company on a path to reach more patients in more prevalent indications with the new bispecific TCR modality. 

On Wednesday, FDA approved Kimmtrak to treat metastatic or unresectable uveal melanoma in patients expressing the HLA-A*02:01 allele. Uveal melanoma is an ultrarare cancer affecting about 1,700 new patients annually in the U.S., and the patient subset that both harbors the HLA-A*02:01 allele and has metastatic or unresectable disease is even smaller, at about 400 patients...

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