APR 03, 2017
Novartis has announced the European Commission has approved Tafinlar®(dabrafenib) in combination with Mekinist® (trametinib) for treating patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). This approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the European Union (EU), plus Norway and Iceland. It is estimated that every year, up to about 36,000 people, or about 1-3% of patients with lung cancer, are diagnosed with BRAF V600-positive NSCLC worldwide.
Bruno Strigini, CEO, Novartis Oncology, said: “Today’s approval represents an important milestone for the lung cancer community, especially those patients living with the BRAF V600 mutation who previously had few options. At Novartis, we are committed to bringing meaningful scientific advances that fill critical unmet needs to patients.”
This EU approval follows a positive opinion granted in February by the Committee for Medicinal Products for Human Use (CHMP), which was based on efficacy and safety of dabrafenib in combination with trametinib in a Phase II, three-cohort, non-randomised, multicentre, 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).