Health Canada approves Yervoy® (ipilimumab) for first-line treatment of adults with metastatic melanoma, the most deadly form of skin cancer

Immunotherapy treatment with long-term survival in some previously treated patients now approved for use in newly diagnosed patients

MONTREAL, Sept. 16, 2014 /CNW/ - Bristol-Myers Squibb Canada is pleased to announce that Health Canada has approved Yervoy^® (ipilimumab) as a first-line therapy in adults with unresectable or metastatic melanoma, the most deadly form of skin cancer. This means that Canadians with newly diagnosed advanced melanoma, regardless of the subtype, will be eligible to receive the novel immunotherapy as their initial treatment.

When Yervoy was first approved by Health Canada in 2012, for the treatment of patients who had failed or did not tolerate other systemic therapy for advanced disease, it was the first and only treatment for advanced melanoma proven to extend survival in a phase 3 trial.

"Yervoy was the first immunotherapy treatment for metastatic melanoma introduced in Canada and it has transformed the way this deadly disease is currently managed. After decades with no new options, physicians suddenly not only had options but we were seeing long-term survival in some pretreated patients who were given Yervoy," said Dr. Michael Smylie, an oncologist specializing in melanoma at the Cross Cancer Institute in Edmonton. "Having Yervoy available now as an initial treatment will allow us to offer this potential benefit earlier in the disease course. This is good news for treating physicians and excellent news for our newly diagnosed patients."

Unlike traditional therapies that target the tumour directly, immuno-oncology is an innovative field of cancer research and treatment focused on harnessing the power of the body's immune system to fight cancer. Such treatments target the very same pathways tumour cells use to evade recognition and destruction. Yervoy specifically blocks cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), which plays a role in suppressing the normal immune response. Yervoy blocks that suppression to allow the immune system to respond to melanoma cancer cells.

"Nine years ago my doctor put me on Yervoy which was experimental at the time.  Having already been through a number of unsuccessful treatments, I did not expect to celebrate another birthday, Christmas or even experience another summer.  This treatment didn't just save my life, it gave me my life back," said Kathy Barnard, founder of the Save Your Skin Foundation, a group dedicated to raising awareness about skin cancer, providing information about treatment options and funding research. "It's hard enough to be diagnosed with advanced melanoma and patients should have every possible chance on their side.  I'm so pleased for what this approval means for newly diagnosed patients.  This just gives more hope to patients in a disease area that only a decade ago had no hope at all." 

Over 30,000 melanoma patients have been treated with Yervoy. Yervoy has been recognized for its innovation by being awarded the Prix Galien Canada 2013 Innovative Product Award and earlier this year was named as one of Canada's top 10 new and emerging health technologies by the Canadian Network for Environmental Scanning in Health in its first "New and Emerging Health Technology Watch List."

Yervoy is the first approved treatment from the Bristol-Myers Squibb immuno-oncology pipeline. The company is committed to leading advances in immuno-oncology and continues to research Yervoy in multiple tumor types.

About melanoma
Melanoma is the deadliest form of skin cancer, accounting for 8% of cases of skin cancer in Canada but 70% of the deaths from the disease. Melanoma accounts for about 3% of all new cancer cases, placing it among the top 10 cancers diagnosed in Canada. An estimated 6,500 Canadians will be diagnosed with melanoma this year and 1,050 will die from it. One in 59 Canadian men and one in 73 Canadian women will develop melanoma in their lifetime. 

Melanoma is characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma occurs when cancer spreads beyond the surface of the skin to other organs, such as the lymph nodes, lungs, brain or other areas of the body. Unresectable melanoma is a melanoma that cannot be removed or resected by surgery. The survival rate for melanoma is high if it is detected early but the advanced form, metastatic melanoma, is an aggressive disease which, until recently, was characterized by high mortality.

About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bmscanada.ca.

YERVOY is a registered trademark of Bristol-Myers Squibb Company.

SOURCE: Bristol-Myers Squibb Canada

Monica Flores, Senior Manager, Public Affairs, Bristol-Myers Squibb Canada, 514-333-3845, [email protected]