Oncology history: Immunocore claims first-ever FDA approval of melanoma drug

pharmafile | January 27, 2022 | News story | Business Services  

Immunocore has claimed a piece of history in biotech industry, becoming the first company to secure an FDA approval for a T-cell receptor (TCR) technology-based cancer therapeutic.

The FDA cleared the company’s lead TCR, Kimmtrak®, a bispecific T-cell engager (BiTE). Bispecifics are antibodies that bind to two different antigens. Kimmtrak is made up of a soluble TCR targeting gp100, expressed on cancer cells, fused to a protein that binds CD3 receptors on lymphocytes. Lymphocytes are white blood cells that function in the immune system by recognising and deactivating specific foreign substances. The TCR has been approved as a treatment for unresectable or metastatic uveal melanoma.

As well as being the first TCR, it also becomes the first BiTE drug to be approved to treat a solid tumour, and the first approved therapy for uveal melanoma, a form of cancer affecting the eye. Immunocore has shared that it will launch Kimmtrak within a matter of weeks, and that the therapeutic is also under regulatory review in the EU, UK, Canada and Australia.

Kimmtrak’s approval establishes many firsts as the first TCR therapeutic to receive regulatory approval from the FDA. The treatment is the first bispecific T-cell engager to receive regulatory approval from the FDA to treat a solid tumour, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

“Every year in the US, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options,” said Immunocore chief executive Bahija Jallal. “Kimmtrak is the first therapy to demonstrate a survival benefit to patients with this disease,” Jallal continued.

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said John Kirkwood, MD, director of the Melanoma Centre at the UPMC Hillman Cancer Centre. “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.”

Ana Ovey

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