Novartis picks up FDA approval for targeted lung cancer meds Tafinlar, Mekinist

Patients in the U.S. with a specific lung cancer will soon have their first targeted treatment option with Novartis’ FDA approval for Tafinlar plus Mekinist.

U.S. drug regulators signed off on the combo to treat metastatic non-small cell lung cancer (NSCLC) with the BRAF V600E mutation on Thursday based on phase 2 study results showing that more than 60% of treatment-naive and previously treated patients responded to the treatment.

BRAF mutations occur in about 1% to 3% of NSCLC cases around the world, according to Novartis, while BRAF V600E tumors are aggressive and leave patients with a poor prognosis.

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Following the approval, the Swiss drugmaker’s oncology head, Bruno Strigini, said in a statement that the patient group has “responded less favorably to standard chemotherapy, suggesting that there is a critical need for a targeted therapy.”

The combo is available now at a price before discounts of $19,642.59 for a 30-day supply, a Novartis spokesperson told FiercePharma. Further, the drugmaker estimates that it provides support to about half of patients on the combo through an assistance program, copay cards and other means.

Picked up in Novartis’ big asset swap with GlaxoSmithKline, the combo won European approval to treat the specific lung cancer type back in March. Tafinlar targets the BRAF mutation, while Mekinist is a MEK inhibitor with a complementary mechanism of action.

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About 36,000 new cases of the specific lung cancer are diagnosed each year, according to the World Health Organization. It’s a small patient pool, but sales in the indication are projected to reach $318 million for Tafinlar and $278 million by 2025, according to analysts with GlobalData.

The drugs generated about $672 million in total sales last year.

Tafinlar and Mekinist won their initial approvals in BRAF-positive advanced melanoma, where they compete with Roche's BRAF-targeted Zelboraf and Cotellic. Back in 2015, the FDA granted the Tafinlar and Mekinist combo a breakthrough therapy designation in the lung cancer type.

As Novartis’ asset swap with GSK illustrates, it’s been amping up its focus in oncology and recently split its drug business into two units: pharmaceuticals and oncology.