Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The Company also announced that the US Food and Drug Administration (FDA) has granted priority review for the same patient population.

"The CHMP positive opinion and FDA priority review of Tafinlar and Mekinist validate the importance of this targeted therapy combination for patients with the most serious form of skin cancer," said Bruno Strigini, President, Novartis Oncology. "This good news for the combination of Tafinlar and Mekinist in metastatic melanoma follows on the FDA's recent Breakthrough Therapy designation for the combination in BRAF V600 mutation-positive non-small cell lung cancer. We look forward to working with the US and EU regulatory authorities to help bring this targeted therapy combination to more patients who may benefit."

For more details, go to: https://www.novartis.com/news/media-releases/novartis-combination-therapy-tafinlar®-and-mekinist®-achieves-important-eu-and