Novartis could get first targeted treatment for patients with BRAF non-small cell lung cancer if European Medicines Agency (EMA) approves Tafinlar+Mikinist combination.
Novartis said on Friday that it got a recommendation approval of Tafinlar combined with Mekinist for certian non-small cancer from the Committee for Medicinal Products for Human Use (CHMP) of the EMA.
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.
The European Commission (EC) could make the decision in two months. Novartis noted that the EC usually adheres to the recommendation of the CHMP. The decision will be applicable to all 28 European Union (EU) 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 US Food and Drug Administration (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 tumors tested positive for the BRAF V600 mutation.