EU approves Mekinist for BRAF V600 Metastatic Melanoma-GSK

The European Commission has granted marketing authorisation for Mekinist (trametinib), from Glaxo Smith Kline, as a single agent in the treatment of adult patients with unresectable or Metastatic Melanoma with a BRAF V600 mutation. Trametinib has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.

The decision is based on results from the randomised, open-label Phase III METRIC study of 322 patients with BRAF-mutant melanoma (types V600E and V600K) who were treatment-na�ve or may have received one prior chemotherapy treatment in the metastatic setting. Treatment with trametinib resulted in a statistically significant increase in progression-free survival (PFS) compared to chemotherapy with a median PFS of 4.8 months for patients taking trametinib compared to 1.5 months for chemotherapy. The submission also included a single-arm Phase II study which evaluated the objective response rate, safety, and pharmacokinetics of trametinib. The most common adverse reactions include rash, diarrhoea, fatigue, oedema peripheral, nausea, and dermatitis acneiform.