3 April 2017 - Approval based on data showing more than 60% overall response rate in both previously treated and untreated patients.

Novartis today announced the European Commission has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small-cell lung cancer (NSCLC). The 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 Iceland and Norway. Every year, it is estimated, up to about 36,000 people, or about 1-3% of patients with lung cancer, are diagnosed with BRAF V600-positive NSCLC worldwide.

"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," said Bruno Strigini, CEO, Novartis Oncology. "At Novartis we are committed to bringing meaningful scientific advances that fill critical unmet needs to patients."

Today's EU approval follows a positive opinion granted in February by the CHMP, which was based on safety and efficacy of dabrafenib in combination with trametinib in a Phase II, three-cohort, multicenter, non-randomised 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).

Read Novartis press release