The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations.
According to the company, Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.
The combination was granted a priority review by the FDA and is based on the demonstration of response rate and median duration of response in a Phase I/II trial, which evaluated the combination of trametinib and dabrafenib at the recommended dose (150/2mg) (N=54) and single-agent dabrafenib (150mg) (N=54).
The data secured from a Phase I/II trial showed that the investigator-assessed overall response rate was 76% for patients treated with the combination of Mekinist and Tafinlar, versus 54% for those given Tafinlar alone.
Meanwhile, the median duration of response was 10.5 months for patients treated with the combination, compared to 5.6 months for the patients treated with single-agent dabrafenib.
The accelerated approval is contingent on the results of the ongoing Phase III trial called 'MEK115306 or Combi-D', which is aimed at evaluating the clinical benefit of the combination in patient population.
According to the company, the combination of Trametinib and dabrafenib can cause serious side effects, some of which can be life threatening.
Image: GlaxoSmithKline headquaters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton