Immunocore’s KIMMTRAK for Unresectable or Metastatic Uveal Melanoma Gets FDA Approval
Mohammed Dar, head of clinical development and chief medical officer of Immunocore said that approximately 1,700 people in the US are diagnosed with uveal melanoma each year. This diagnosis means loss of vision in the damaged eye, and in about 50% of cases, the disease recurs and metastasizes to other organs.
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, Pittsburgh.
Commercial stage biotech drug developer Immunocore Holdings announced on Wednesday that the FDA has granted marketing approval for KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). The drug also becomes the first T cell receptor (TCR) therapeutic to receive regulatory approval from the agency and the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor.
The approval of KIMMTRAK 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.The approval was based on the results of the Phase III IMCgp100-202 clinical trial, published on September 23, 2021 in the New England Journal of Medicine
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