Novartis receives positive CHMP opinion for Tafinlar + Mekinist in BRAF-positive NSCLC patients

If approved, Tafinlar + Mekinist will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation.

Novartis has 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.

"At Novartis, we are committed to finding treatments for rare cancers with an unmet need. Today's CHMP opinion marks a major milestone for NSCLC patients with the BRAF V600 mutation, who have very limited treatment options," said Bruno Strigini, CEO, Novartis Oncology. "We welcome the CHMP's opinion as a first step towards that goal, and look forward to continuing to work with European health authorities to make Tafinlar + Mekinist available for appropriate NSCLC patients."

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 tumour 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% and duration of response of 9.0 months. The most common adverse events (incidence >20%) were pyrexia, nausea, vomiting, diarrhea, asthenia, decreased appetite, dry skin, chills, peripheral edema, 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.

The European Commission typically adheres to the recommendation of the CHMP and usually delivers its final decision within two months. The decision will be applicable to all 28 European Union member states plus Iceland and Norway. In Europe, Tafinlar and Mekinist is approved for the treatment of patients with unresectable or metastatic melanoma who have a BRAF V600 mutation.

The FDA granted Tafinlar + Mekinist Breakthrough Therapy Designation for advanced or metastatic BRAF V600-positive NSCLC patients in 2015 and Priority Review in November 2016. Combination use of Tafinlar + Mekinist is also approved in the US, Australia, Canada and additional countries for patients with unresectable or metastatic melanoma whose tumours tested positive for the BRAF V600 mutation.