Posted by Michael Wonder on 24 Feb 2017
Novartis receives positive CHMP opinion for Tafinlar + Mekinist in BRAF-positive non-small-cell lung cancer patients
24 February 2017 - With new targeted therapy, BRAF becomes fourth actionable oncogenic driver of lung cancer, similar to EGFR, ALK and ROS.
Novartis today announced the CHMP of the EMA adopted a positive opinion recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat patients with advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors express the BRAF V600 mutation.
If approved, Tafinlar + Mekinist will be the first targeted treatment available for patients with BRAF V600-positive NSCLC. Of the estimated 1.8 million new cases of lung cancer diagnosed worldwide each year, 1-3%, may be driven by the BRAF mutation.
