FDA approves Mekinist (Glaxo Smith Kline) for BRAF V600E/K Metastatic Melanoma

The FDA has approved Mekinist (trametinib), from Glaxo Smith Kline, as a single-agent oral treatment for unresectable or Metastatic Melanoma in adult patients with BRAF V600E or V600K mutations. Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.

Approval is based on results from the open-label, international Phase III METRIC study of 322 unresectable or Metastatic Melanoma adult patients with a BRAF V600E or V600K mutation, who had no more than one prior chemotherapy regimen. The median PFS was 4.8 months for patients taking trametinib compared to 1.5 months for chemotherapy. Fifty-one patients (47%) crossed over from the chemotherapy arm at the time of disease progression to receive trametinib. The most common adverse reactions included rash and diarrhoea.