FDA approves Tafinlar + Mekinist for Metastatic Melanoma-GSK

The FDA has approved Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib), both from Glaxo Smith Kline, for the use treatment of patients with unresectable Melanoma or Metastatic Melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.

The approval is based on the demonstration of response rate and median duration of response in a Phase I/II study. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The combination was approved through the FDA's Accelerated Approval programme and is contingent on the results of the ongoing Phase III trial (referred to as MEK115306 or Combi-D), which is designed to evaluate the clinical benefit of the combination in this patient population.

The results from the randomised Phase II part of the study showed an overall response rate was 76% for patients treated with the combination, and 54% for patients treated with single-agent dabrafenib. The median duration of response was 10.5 months for patients treated with the combination, and 5.6 months for patients treated with single-agent dabrafenib.