GSK marketed products Mekinist in combination with Tafinlar received FDA nod for Advanced Melanoma

 

FDA approved combination therapy of Mekinist (trametinib) and Tafinlar (dabrafenib) for treatment of advanced melanoma that is unresectable or metastatic. In May 2013, FDA had already approved both drugs as single agents to treat patients with unresectable or metastatic melanoma, skin cancer.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said, “Mekinist and Tafinlar are the first drugs approved for combination treatment of melanoma.” He further added, “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.”

The safety and effectiveness of combination therapy were demonstrated in a clinical trial of 162 participants with unresectable or metastatic melanoma with the BRAF V600E or V600K mutation, most of whom had not received prior therapy. Participants received either Mekinist in combination with Tafinlar or Tafinlar as a single agent until their melanoma progressed or side effects became intolerable.

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.


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