Tafinlar™ and Mekinist™ approved in Canada for metastatic melanoma

Melanoma patients with BRAF V600 mutation have two new treatment options in their fight against this aggressive and deadly form of cancer

MISSISSAUGA, ON, July 24, 2013 /CNW/ - Health Canada has approved Tafinlar™ (dabrafenib mesylate) and Mekinist™ (trametinib) for patients with unresectable (melanoma that cannot be removed by surgery) or metastatic (melanoma which has spread to other parts of the body) melanoma.

Tafinlar™, a BRAF-inhibitor, is indicated as a monotherapy oral treatment for unresectable melanoma or metastatic melanoma in adult patients with BRAF V600 mutation¹.  Mekinist™, a first in class MEK-inhibitor, is also indicated as a monotherapy oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600 mutation².  For both treatments, a validated test is required to identify BRAF V600 mutation status.

"Health Canada's approvals of Tafinlar™ and Mekinist™ represent an important step in GSK's ongoing effort to bring new treatment options to cancer patients as quickly and efficiently as possible," says Rav Kumar, Vice President R&D Operations/Business Development, GSK Canada. "With Tafinlar™ and Mekinist™, we hope to make a meaningful difference in the lives of patients living with metastatic melanoma, a devastating disease associated with very low survival rates and limited treatment options."

Melanoma is one of the top seven most frequent cancers in Canada (affecting an estimated 6,000 people in 2013 and causing 1,027 deaths).³ In North America, one person dies from melanoma every hour and it causes 75 per cent of skin cancer-related deaths.⁴  If found early and confined to the skin, melanoma can usually be removed with surgery, but sometimes melanoma can spread to other parts of the body, a process referred to as metastasis. Typically, less than five per cent of all new melanoma patients present with metastatic disease.

"Metastatic melanoma is a devastating diagnosis for Canadian patients and their families," says Glenn Crater, Country Medical Director for GlaxoSmithKline Inc. "As a result, the approvals of Tafinlar™ and Mekinist™ are good news for this patient community and offer two new options for doctors and patients fighting this serious and deadly form of skin cancer."

About Melanoma and Metastatic Melanoma
In Canada, the incidence of melanoma has more than tripled over the last 30 years and continues to increase.⁵  Melanoma is one of the few cancers to affect young adults and is the second most common cancer amongst 15-34 year olds.⁶  Roughly 6,000 (3,300 males and 2,700 females) Canadians will be diagnosed with melanoma in 2013, and 1,027 (630 males and 397 females) will die from the disease.⁷ Survival rates for melanoma are high if it is detected early. Historically, in its late stages, the median survival rate has been just six months, and at one year only 25 per cent of metastatic melanoma patients are still alive.⁸

About Tafinlar™ and Mekinist™
Tafinlar™ will be available in 50mg and 75mg capsules. Mekinist™ will be available in 0.5 mg and 2.0 mg tablets.

About GlaxoSmithKline
GlaxoSmithKline is a leading research-based pharmaceutical company with a challenging and inspiring mission: to improve the quality of life by enabling people to do more, feel better, and live longer. This mission gives GSK the purpose to develop innovative medicines, vaccines and healthcare solutions that help millions of people. Discover more at GSK.ca

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk factors' in the Annual Report for GlaxoSmithKline plc.

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¹ Tafinlar Product Monograph, GlaxoSmithKline Inc., 2013
² Mekinist Product Monograph, GlaxoSmithKline Inc., 2013
³ Melanoma Network of Canada. Available online at: http://www.melanomanetwork.ca/facts-summary/.
⁴ Ibid.
⁵ Melanoma Network of Canada. "Fact Sheet - Ultraviolet Radiation and Melanoma." Available online at: http://www.melanomanetwork.ca/wordpress/wp-content/uploads/2012/11/FACT_SHEET_UV_Radiation-and-Melanoma2013.pdf.
⁶ Cancer Care Nova Scotia. "Skin Cancer Statistics." Available online at: http://www.cancercare.ns.ca/site-cc/media/cancercare/Skin_Cancer_Statistics.pdf
⁷ Canadian Cancer Statistics, 2013 Special topic: lung cancer. "Per cent distribution of estimated cancer deaths, by sex, Canada, 2013."
⁸ Korn, Liu et al. 2008.

SOURCE: GlaxoSmithKline Inc.

David Mircheff
Environics Communications
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Janet Grdovich
Communications Manager
GlaxoSmithKline Inc.
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