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)
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
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
"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.
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
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/.
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:
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.
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