Novartis' combination therapy Tafinlar + Mekinist granted FDA Priority Review

If approved, Tafinlar + Mekinist expected to be the first adjuvant targeted therapy combination to demonstrate a significant clinical benefit in patients with a BRAF V600 mutation.

"The FDA's decision to grant Tafinlar in combination with Mekinist Breakthrough Therapy designation and Priority Review designation validates the potential of the combination to have a significant impact on the lives of melanoma patients treated in the adjuvant setting," said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development. "There remains a need to address the high risk of recurrence seen in these patients and improve the quality of care they receive."

Priority Review designation is based on results from COMBI-AD, a Phase III study evaluating Tafinlar + Mekinist in patients with stage III BRAF V600E/K mutation-positive melanoma after complete resection. The study met its primary endpoint by significantly reducing the risk of disease recurrence or death by 53% versus placebo. The combination treatment group also showed an improvement in the key secondary endpoint of OS . Other secondary endpoints where the combination demonstrated a clinically meaningful benefit include DMFS, and FFR.

Tafinlar in combination with Mekinist is currently approved in the US for patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation as detected by an FDA-approved test and non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.