FDA approves Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation.- Novartis

Novartis has announced the FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation. The FDA granted Tafinlar + Mekinist Breakthrough Therapy designation in July 2015 for the treatment of patients with advanced or metastatic BRAF V600E mutation-positive NSCLC who received previous treatment with chemotherapy.

The FDA approval is based on safety and efficacy of Tafinlar in combination with Mekinist in a Phase II, three-cohort, multicenter, non-randomized, non-comparative and open-label study in which patients with stage IV BRAF V600E mutant NSCLC were enrolled (36 treatment-naïve [previously untreated] and 57 previously treated with chemotherapy).

The Phase II, three-cohort, multicenter, non-randomised and open-label study included patients with late-stage disease, which also formed the basis of European approval in March. In the trial, 36 treatment-naïve patients receiving 150mg of Tafinlar twice daily and 2mg of Mekinist once daily demonstrated an objective response rate of 61 percent. In this population, 68 percent of patients had not progressed after nine months. In the previously treated population receiving the same dosage, patients demonstrated an ORR of 66.7 percent. The response was durable with a median DoR reaching 9.8 months.

Comment:B RAF mutations occur in around 1-3 percent of NSCLC cases worldwide. Novartis says there is an urgency to treat people with this mutation, as BRAF V600E mutation-positive tumours have been shown to be more aggressive and may lead to a poorer prognosis.