England-based biotech Immunocore has won FDA approval for the first-ever treatment for a rare and aggressive form of eye cancer.
Immunocore's Kimmtrak is the first T-cell receptor therapeutic to receive regulatory approval from the FDA, as well as the first and only therapy approved by the agency for the treatment of unresectable or metastatic uveal melanoma. It works by redirecting and killing tumor cells, giving patients a greater chance of survival, with clinical trials finding it extended patient survival rates by about five months and reduced the risk of death by about 50%.
The FDA’s approval of Kimmtrak comes a month earlier than the originally assigned PDUFA date, and five months after regulators in the U.S. and Europe accepted the company’s application.
“The approval of Kimmtrak represents not only a new therapy but a new hope for the individuals and the families of those diagnosed with the deadliest form of eye cancer,” said Kyleigh LiPira, CEO of the Melanoma Research Foundation.
The drug’s application has also been accepted by the European Medicines Agency, the UK Medicines and Healthcare Agency, Health Canada and the Australian Government Department of Health Therapeutic Goods Administration.
To increase accessibility, the company launched a global early access program making the treatment available to over 200 mUM patients in 13 countries. Immunocore says it is ready to commercialize Kimmtrak and expects the product to become available in the U.S. in the coming weeks.
