Novartis receives approval for new Tafinlar/Mekinist regimen for lung cancer

Novartis has announced that its new combination therapy regimen for lung cancer has been approved by the European Commission.

The regulator has approved the use of Tafinlar in combination with Mekinist for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC), marking the first targeted treatment to be approved for this patient population.

The safety and efficacy of this regimen has been demonstrated in a three-cohort phase II study, in which patients with stage IV BRAF V600E mutant NSCLC were enrolled, with the treatment offering strong overall response and progression-free survival rates.

Bruno Strigini, chief executive officer at Novartis Oncology, said: "Today's approval represents an important milestone for the lung cancer community, especially those patients living with the BRAF V600 mutation, who previously had few options."

This therapeutic combination is also approved in the US, Europe, Australia, Canada and additional countries for patients with unresectable or metastatic melanoma whose tumours test positive for the BRAF V600 mutation.

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