The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's Tafinlar (dabrafenib) and Mekinist (trametinib) as single-agent therapies for unresectable or metastatic melanoma with BRAF V600E mutation.
Tafinlar is not indicated for the treatment of patients with wild-type BRAF melanoma, whereas Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.
GSK oncology president Paolo Paoletti said that with FDA approvals, the company can now offer two new single-agent therapies to selected patients who have metastatic melanoma, a devastating disease with very low survival rates and few treatment options.
Tafinlar is approved for patients with the BRAF V600E mutation, which accounts for about 85% of all BRAF V600 mutations in metastatic melanoma while Mekinist is approved for patients with the V600K mutation along with BRAF V600E mutation.
The approval was based on clinical studies, which studied and demonstrated the efficacy and safety of the products, including identification of warnings and precautions.
The two new single-agent therapies are expected to be available for prescription in the early third quarter of 2013.
