- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves Combination Use of Mekinist (Trametinib) and Tafinlar (Dabrafenib) for Melanoma
First targeted combo therapy for patients with BRAF V600E or V600K mutations (January 9)
The FDA has approved Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable or metastatic melanoma. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for the treatment of patients with wild-type BRAF melanoma.
Both Mekinist and Tafinlar are marketed by GlaxoSmithKline.
The approval of the combination therapy was based on the demonstration of a response rate and a 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 program and was reviewed under a priority review designation. This accelerated approval is contingent on the results of an ongoing phase III trial, which is designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma.
Trametinib in combination with dabrafenib can cause serious side effects, some of which can be life threatening, including: new primary cutaneous malignancies, tumor promotion in wild-type BRAF melanoma, hemorrhagic events, venous thromboembolic events, cardiomyopathy, ocular toxicities, interstitial lung disease, serious febrile drug reactions, serious skin toxicity (rash), hyperglycemia, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, and embryofetal toxicity.
Source: GlaxoSmithKline; January 9, 2014.