Save Your Skin Foundation

Save Your Skin Foundation

September 29, 2015 08:00 ET

Immunotherapy a Hot Topic at ECC 2015 While Canada Approves Opdivo for Metastatic Melanoma

Save Your Skin Foundation commends Health Canada's decision to approve new immunotherapy for Canadians living with this disease

MONTREAL, QUEBEC--(Marketwired - Sept. 29, 2015) - The Save Your Skin Foundation was in Vienna, Austria this month for the European Cancer Congress (ECC) 2015, where the hot topics were immunotherapy and rare cancers. While the Canadian Foundation was at ECC 2015 discussing global advocacy and new treatments, it was also focused on Canada and the approval of immunotherapy Opdivo™ (nivolumab) for the treatment of previously untreated BRAF 4600 Wild-Type metastatic melanoma.

The Save Your Skin Foundation commends Health Canada's decision to approve the new immunotherapy for Canadians living with this disease - a decision that marks another important milestone for patients.

Opdivo, from Bristol-Meyers Squibb, is the first anti PD-1 (programmed death-1) approved to treat previously untreated cases of BRAF 4600 wild-type unresectable or metastatic melanoma in adults. The approval was made under the Health Canada Priority Review process after having met the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies.

"Metastatic melanoma has now gone from being defined as a deadly disease to a disease with people who are surviving. This approval is someone's opportunity to live a longer life," said Kathy Barnard, metastatic melanoma survivor and Founder and President of the Canadian Save Your Skin Foundation. "The results of ongoing research are giving patients treatments options that, not long ago, did not exist. This is a remarkable accomplishment. I'm here today witnessing history being made. I'm living proof that timely access to new treatments can save lives."

The U.S. Food and Drug Administration (FDA) also announced that it has accepted for filing and review a supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen to include clinical data from CheckMate-067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of January 23, 2016. The Save Your Skin Foundation hopes that Canada will soon follow with a similar announcement.

Metastatic Melanoma in Canada

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment- producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease, and occurs when cancer spreads beyond the surface of the skin to the other organs, such as the lymph nodes, lungs, brain or other areas of the body. An estimated 6,800 Canadians will be diagnosed with melanoma in 2015 and 1,150 will die from it. Melanoma accounts for 3% of all cancer diagnoses in Canada, making it one of the top 10 cancers diagnosed in Canada. The incidence of melanoma has been increasing significantly in Canada during the past several decades. Between 2001 and 2010, incidence increased 2.3% per year for men and 2.9% per year for women.

About the Save Your Skin Foundation

The Save Your Skin Foundation is a national not-for profit organization dedicated to the areas of skin cancer and skin disease with a focus on education and awareness, supporting research and ensuring equal and timely access to treatment for all Canadians. Please visit www.saveyourskin.ca for more information.

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