FDA approves drug to treat advanced melanoma

Posted on Saturday, January 11, 2014 at 6:50 pm

The U.S. Food and Drug Administration has approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage).

In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma. Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease. The National Cancer Institute estimated that 76,690 Americans would be diagnosed with melanoma and 9,480 would die from the disease in 2013.

“Mekinist and Tafinlar are the first drugs approved for combination treatment of melanoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Their development for combination use is based on the strong understanding of the biological pathways of the disease. This approval illustrates the value of continuing to study drugs in combination for clinical development.”

Results showed that 76 percent of participants treated with Mekinist in combination with Tafinlar had their cancer shrink or disappear (objective response) that lasted an average of 10.5 months. In contrast, 54 percent of participants treated with Tafinlar as a single agent experienced objective responses that lasted an average of 5.6 months. Clinical trials are ongoing to determine whether Mekinist in combination with Tafinlar improves survival.

The most common side effects reported in participants receiving Mekinist in combination with Tafinlar included fever, chills, tiredness, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema (swelling in the hands and feet), cough, headache, joint pain, night sweats, decreased appetite, constipation and muscle pain. During clinical testing, the incidence and severity of fever increased when Mekinist was used in combination with Tafinlar.

Serious side effects included bleeding, clot formation, heart failure, skin problems and eye problems. One of the serious side effects of Tafinlar — the development of a new squamous cell carcinoma of the skin — was reduced when the drug was used in combination with Mekinist. The incidence of squamous cell carcinoma of the skin in this trial was 7 percent with the combination compared to 19 percent with single agent Tafinlar.

Other clinically significant side effects include kidney injury.

Women of child bearing potential should be advised that Mekinist and Tafinlar can cause birth defects in a developing fetus. Men and women should also be advised that Mekinist and Tafinlar treatment may cause infertility.

Mekinist and Tafinlar are marketed by GlaxoSmithKline, based in Research Triangle Park, N.C.

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