FDA Approves First Combination Therapy for Treatment of Melanoma

The first ever combination drug treatment for melanoma has just been approved by the U.S. Food and Drug Administration (FDA). According to U.S. News and World report, the two medicines "are the first drugs approved for combination treatment of melanoma," via Dr. Richard Pazdur, 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."

The combined treatment has been approved for patients with melanoma that cannot be removed via surgery or late-stage melanoma that has metastasized.

Both the drugs-Mekinist (trametinib) and Tafinlar (dabrafenib) were approved last year by the FDA to be used individually. Yet the combination treatment works to block cellular signaling in different sites of the same molecular pathway that promotes cancer cell growth.

Clinical trials showed that 76 percent of patients involved in studies with the combination treatment had their cancer shrink or disappear for an average of 10.5 months. However, those treated with Tafinlar alone (54 percent) saw their cancer shrink or disappear for approximately 5.6 months.

Side effects reported by patients who received the dual treatment include tiredness, rash, fever, chills, vomiting, diarrhea, abdominal pain, swelling of the hands and feet, headache, joint pain, night sweats, decreased appetite, constipation and muscle pain. More serious effects may involve bleeding, blood clots, heart failure, eye problems, skin problems and kidney damage.