1 September 2015 - Novartis today announced that the European Commission has approved the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. This is the first targeted therapy combination approved in the EU to treat patients with the most aggressive form of skin cancer, demonstrating improved overall survival versus the current standard of care with BRAF inhibitor monotherapy in two Phase III studies.

"We look forward to making the Tafinlar and Mekinist targeted combination treatment, which demonstrated a significant overall survival benefit in two robust clinical trials, available across Europe as soon as possible," said Bruno Strigini, President, Novartis Oncology. "Today's EU approval further demonstrates our ongoing commitment to deliver medicines that can further enhance outcomes for patients with metastatic melanoma."

Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates; approximately one out of every five people will survive for five years following a diagnosis with late-stage disease. There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations[1,6]. Gene tests can determine whether a tumor has a BRAF mutation, and results can play a key role in prognosis and determining appropriate treatment.

For more details, go to: https://www.novartis.com/news/media-releases/novartis-receives-eu-approval-tafinlar®-and-mekinist®-first-combination-approved