-- Scott Roberts
FRIDAY, Jan. 10, 2014 (HealthDay News) -- The U.S. Food and Drug
Administration on Friday approved Mekinist for use with another
drug, Tafinlar, to treat advanced melanoma that is spreading or
cannot be removed by surgery.
Melanoma is the most deadly form of skin cancer, accounting for
an estimated 9,480 American deaths last year, the FDA said Friday
in a news release. Mekinist (trametinib) is newly approved to be
used in combination with Tafinlar (dabrafenib). Both drugs were
first sanctioned in May 2013 to be used by themselves to battle
advanced melanoma, the agency said.
The combination therapy is newly approved for people who have
certain mutations in the BRAF V600E and V600K genes, the FDA said.
About half of melanoma cases have the mutated genes.
The combination therapy was clinically evaluated in 162 people.
Of those treated, 78 percent had their cancer shrink or disappear
for an average of 10.5 months, the agency said.
The most common side effects included fever, chills, rash,
fatigue, nausea, diarrhea, abdominal pain and swelling of the arms
and feet. More serious adverse reactions included bleeding, blood
clots, heart failure, and skin and eye problems.
The drug combination can cause infertility and birth defects,
the agency said, warning men and women of child-bearing age.
Both drugs are marketed by GlaxoSmithKline, based in Research
Triangle Park, N.C.
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