Save Your Skin Foundation

Save Your Skin Foundation

August 18, 2011 19:11 ET

Save Your Skin Foundation Hopes for Canadian Approval of Another New Melanoma Treatment

Another U.S. Approval of New Melanoma Treatment Offers More Hope for Canadians

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Aug. 18, 2011) - U.S. Food and Drug Administration approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer. Zelboraf is specifically indicated for the treatment of patients with melanoma whose tumors express a gene mutation called BRAF V600E. The drug has not been studied in patients whose melanoma tests negative for that mutation by an FDA approved diagnostic.

Zelboraf is being approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient's melanoma cells have the BRAF V600E mutation. The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein. It is the first oral agent for metastatic melanoma.

"The discovery of Zelboraf represents another significant advance in the treatment of melanoma," says Kathy Barnard, Founder of the Save Your Skin Foundation. "As there are few current patient options that extend life, we hope to soon celebrate its availability in Canada."

This news hits a personal note for Barnard, who is currently fighting her own battle with melanoma. In 2003 Barnard was first diagnosed, and by 2005 stage IV malignant melanoma had spread. Tumors were found in her left lung, kidney, liver, and adrenal gland. Kathy is currently in remission but has recently been tested positive with the cobas 4800 BRAF V600 Mutation test. "Zelboraf gives melanoma patients even more hope in their fight with melanoma," says Barnard.

Zelboraf's safety and effectiveness were established in a single international trial of 675 patients with late-stage melanoma with the BRAF V600E mutation who had not received prior therapy. Patients were assigned to receive either Zelboraf or dacarbazine, another anti-cancer therapy. The trial was designed to measure overall survival (the length of time between start of treatment and death of a patient).

The median survival (the length of time a patient lives after treatment) of patients receiving Zelboraf has not been reached (77 percent still living) while the median survival for those who received dacarbazine was 8 months (64 percent still living).

"The approval of Zelboraf by the U.S. F.D.A. marks a major advance in the treatment of metastatic melanoma," said Dr. Michael Smylie. "Metastatic melanoma is one of the most aggressive cancers in humans and treatment until recently has been mostly futile. Melanoma patients now have an effective treatment option available to them with at least 50% of all patients getting a significant response, and future discoveries will hopefully be able to give even more successful treatment outcomes."

About Melanoma in Canada

Every year, thousands of Canadians are diagnosed with Melanoma, with the incidence of the disease increasing faster than that of any other cancer. One in 74 men and 1 in 90 women are expected to develop melanoma during their lifetime; 1 in 284 men and 1 in 486 women will die of it. It is the most dangerous type of skin cancer, causing 75% of deaths associated with skin cancer. Currently in Canada, there is no treatment proven to extend the lives of people diagnosed with metastatic (advanced) melanoma, despite the rising incidence of the disease.

About the Save Your Skin Foundation

The Save Your Skin Foundation was created by family, friends, and colleagues of Founder Kathy Barnard, who is currently battling melanoma. Save Your Skin is a Canadian based not-for-profit Foundation. Through events and other initiatives, the Foundation focuses on raising funds for education and awareness, providing emotional and financial support to those dealing with skin cancer, and on supporting the ongoing research and treatment of skin cancer. Donations go towards providing critical and timely treatments, as well as ongoing education, research, and awareness initiatives.

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