Immunocore Gets FDA OK of Kimmtrak in Uveal Melanoma

By Colin Kellaher

Immunocore Holdings PLC on Wednesday said the U.S. Food and Drug Administration has approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

The Oxfordshire, U.K., biotechnology company said it is ready to commercialize Kimmtrak, and that it expects to make the drug commercially available in the U.S. within weeks.

Immunocore said Kimmtrak is the first TCR therapeutic to receive FDA approval, the first bispecific T-cell engager approved by the FDA to treat a solid tumor, and the first and only therapy approved by the agency for the treatment of unresectable or metastatic uveal melanoma, the most common primary cancer within the eye in adults.

Regulatory agencies in Europe, the U.K., Canada and Australia are currently reviewing Kimmtrak.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 26, 2022 07:35 ET (12:35 GMT)

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