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 mutation(1). 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 mutation(2). 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
"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 GlaxoSmithKline plc.
(1) Tafinlar Product Monograph, GlaxoSmithKline Inc., 2013
(2) Mekinist Product Monograph, GlaxoSmithKline Inc., 2013
(3) Melanoma Network of Canada. Available online at:
(5) Melanoma Network of Canada. "Fact Sheet - Ultraviolet Radiation and
Melanoma." Available online at:
(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.
David Mircheff Environics Communications 416-969-2776
Janet Grdovich Communications Manager GlaxoSmithKline Inc. 7333 Mississauga Rd
Mississauga, ON L5N 6L4 Tel: 905-819-3363
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