Ocumel Canada and Save Your Skin Foundation Applaud Health Canada's approval of KIMMTRAK® (tebentafusp) for the Treatment of Unresectable or Metastatic Uveal Melanoma
TORONTO, June 10, 2022 /CNW/ - Earlier this week, Health Canada granted a Notice of Compliance (NOC) for KIMMTRAK® (tebentafusp) for the treatment of an aggressive form of ocular melanoma, closely following approvals in the United States, Australia, and the European Union.
Ocular melanoma is rare, affecting approximately five in a million people; about 200 cases are diagnosed per year in Canada. Like other melanomas, it begins in melanocytes – the cells that produce the pigment melanin that colours the skin, hair, and eyes, as well as forms moles. While it represents only 5% of melanomas, ocular melanoma is rapid and aggressive, accounting for 9% of melanoma deaths. Also referred to as uveal melanoma, ocular is a more inclusive term; 90% of primary ocular melanoma develops in the choroid.
"For years, metastatic uveal melanoma patients have had to make do with therapeutic options not ideally suited for their condition," said Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Medical Oncology Site Lead at Princess Margaret Cancer Centre in Toronto, Canada, and Ocular Melanoma Physician Task Force of Canada co-Lead. "Today's approval of tebentafusp represents a paradigm shift in the treatment of unresectable or metastatic uveal melanoma and offers patients new hope and a chance at longer survival."
"We have been waiting forever for this day," says Nigel Deacon, Ocular Melanoma survivor and advocate. "Ocular melanoma patients across Canada will be thrilled to hear that Kimmtrak has been approved by Health Canada and for the first time, a specific treatment for metastatic ocular melanoma, a universally fatal cancer, will now be available to extend life and give hope, where before there was none."
As part of patient advocacy, Save Your Skin Foundation is approved to submit treatment recommendations to CADTH common drug review, pCODR (pan-Canadian Oncology Drug Review) and INESSS (Institut national d'excellence en santé et en services sociaux) from the patient perspective. Thank you to all patients and their caregivers who shared their experience and feedback to this process.
We hope that every province and territory will take swift steps to list this drug on their public formularies in order to make this therapy available to patients.
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.
Ocumel Canada, an initiative of Save Your Skin Foundation, was formed to increase awareness, advance treatment options, and build a supportive community for those diagnosed with primary and/or metastatic ocular melanoma (OM). Ocumel Canada is in close collaboration with a global Medical Advisory Board and partner patient representation organizations with the endeavour to build on international best practices to improve patient outcomes for Canadians touched by this disease.
SOURCE Ocumel Canada
Amy Rosvold, [email protected], 778-317-1485
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