Immunocore obtains FDA blessing for Kimmtrak

Immunocore has received clearance from the Food and Drug Administration for Kimmtrak (tebentafusp-tebn) for the treatment of HLA-A 02:01-positive adult patients with unresectable or metastatic uveal melanoma.

“Today’s approval of Kimmtrak is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options,” Bahija Jallal, CEO of Immunocore, said. “Kimmtrak is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making Kimmtrak available as quickly as possible.”

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Kimmtrak is the first TCR therapeutic to receive regulatory approval from the FDA, the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

“We’re also proud to have developed the world’s first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need,” Jallal said.

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“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said John Kirkwood, director of the Melanoma Center at the UPMC Hillman Cancer Center. “The approval of Kimmtrak (tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer.”