Novartis receives CHMP backing for new combination lung cancer therapy

Novartis has announced that its new Tafinlar/Mekinist combination lung cancer therapy has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended Tafinlar in combination with Mekinist for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours express the BRAF V600 mutation.

Data from a phase II clinical trial has demonstrated the strong response rates and clinical benefits the new regimen can offer in this indication.

If approved by the European Commission, the Tafinlar/Mekinist combination would become the first targeted treatment available for this form of cancer. Of the estimated 1.8 million new cases of lung cancer diagnosed worldwide each year, between one and three percent may be driven by the BRAF mutation.

Bruno Strigini, chief executive officer of Novartis Oncology, said: "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."

The combination is already approved for the treatment of patients with unresectable or metastatic melanoma who have a BRAF V600 mutation.

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