CHMP recommends Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat metastatic non small cell lung cancer.-Novartis

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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 tumours 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.

The positive CHMP opinion was based on safety and efficacy data from a Phase II study of Tafinlar + Mekinist in patients with BRAF V600-positive NSCLC (36 treatment-naïve and 57 previously treated with chemotherapy). The 57 patients who had tumor progression on at least one platinum based chemotherapy, receiving 150 mg of Tafinlar twice daily and 2 mg of Mekinist once daily, demonstrated an overall response rate (ORR) of 63.2% (95% confidence interval [CI], 49.3%, 75.6%) and duration of response of 9.0 months (95% CI, 6.9, 18.3 months). The most common adverse events (incidence greater than 20%) were pyrexia, nausea, vomiting, diarrhea, asthenia, decreased appetite, dry skin, chills, peripheral oedema, cough and rash. Updated data from the previously treated and treatment-naïve cohorts were included in the overall data package for EMA review and will also be presented at upcoming medical meetings.

See- Planchard D et al. "Dabrafenib plus trametinib in patients with previously treated BRAFV600E-mutant metastatic non-small cell lung cancer: An open-label, multicentre Phase II trial". 2016. Lancet Oncol 17: 984-93.