FDA OKs 2-Drug Combo Treatment for Advanced Melanoma01/10/14
FRIDAY, Jan. 10, 2014 (HealthDay News) -- The drugs Mekinist and
Tafinlar were approved for combination treatment of advanced
melanoma skin cancer, the U.S. Food and Drug Administration
The two medicines "are the first drugs approved for combination
treatment of melanoma," Dr. Richard Pazdur, director of the Office
of Hematology and Oncology Products in the FDA's Center for Drug
Evaluation and Research, said in an agency news release. "Their
development for combination use is based on the strong
understanding of the biological pathways of the disease," he
The combined treatment was approved for use in patients with
melanoma that cannot be removed by surgery or in people with
late-stage melanoma that has spread. Both drugs were approved by
the FDA last year as single treatments for these groups of
Mekinist (trametinib) and Tafinlar (dabrafenib) block cellular
signaling in different sites of the same molecular pathway that
promotes cancer cell growth, the FDA explained.
The agency's approval of the drugs for combination treatment of
melanoma is based on the results of a clinical trial of 162
patients. It found that 76 percent of patients who received
treatment with Mekinist and Tafinlar had their cancer shrink or
disappear for an average of 10.5 months.
In comparison, 54 percent of patients treated with Tafinlar
alone had their cancer shrink or disappear for an average of 5.6
months, the investigators found.
Clinical trials are underway to determine whether combination
treatment with Mekinist and Tafinlar can boost patient survival,
the FDA added in the news release.
The most common side effects reported by patients who received
the dual treatment included fever, chills, tiredness, rash, nausea,
vomiting, diarrhea, abdominal pain, swelling in the hands and feet,
cough, headache, joint pain, night sweats, decreased appetite,
constipation and muscle pain. Serious side effects included
bleeding, blood clots, heart failure, skin and eye problems, and
Women of childbearing age should be advised that Mekinist and
Tafinlar can cause birth defects, and women and men should also be
told that treatment with Mekinist and Tafinlar may cause
infertility, the FDA stated.
Melanoma is the most aggressive type of skin cancer and the
leading cause of death from skin disease. It was estimated that
76,690 Americans would be diagnosed with melanoma and 9,480 would
die from the disease in 2013, according to the U.S. National Cancer
Mekinist and Tafinlar are marketed by GlaxoSmithKline.
The American Cancer Society has more about
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