First Drug Combination Approved for Unresectable or Metastatic Melanoma

August 2014 Vol 7, Special Issue ASCO 2014 Payers' Perspectives in Oncology - FDA Approvals

On January 8, 2014, the US Food and Drug Administration (FDA) approved the use of dabrafenib (Tafinlar; GlaxoSmithKline) plus trametinib (Mekinist; GlaxoSmithKline) as a new combination therapy for the treatment of patients with advanced melanoma that is unresectable or metastatic. The 2 drugs were individually approved by the FDA in 2013 for melanoma. Each of the 2 drugs blocks molecular signaling in different sites of the same pathway that promotes cancer-cell growth. Dabrafenib was initially approved for patients with melanoma whose tumors express the BRAF V600E mutation. The dabrafenib-trametinib combination is indicated for patients with melanoma who also have the BRAF V600E or BRAF V600K mutation. Approximately 50% of skin melanomas have a BRAF mutation.

The FDA approval was based on the results of a clinical trial of 162 patients with unresectable or metastatic melanoma with the BRAF V600E or BRAF V600K mutation; the majority of the patients were treatment-naïve. They received dabrafenib as a single agent until their disease progressed or until their side effects became intolerable, at which point they began using the combination. Overall, 76% of patients receiving the combination had an objective response for an average of 10.5 months compared with 54% of patients receiving dabrafenib alone who had an objective response lasting 5.6 months. Clinical trials are ongoing to determine whether this combination will also result in improved survival.

The side effects reported with the combination are similar to those reported with each individual drug.

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Last modified: August 21, 2014
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