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.
According to Novartis, this is the first targeted therapy combination approved in the EU to treat patients with the most aggressive form of skin cancer.
“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.”
Novartis explains that 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. Gene tests can determine whether a tumor has a BRAF mutation, and results can play a key role in prognosis and determining appropriate treatment.
The European Commission approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein.
In the US, the Food and Drug Administration (FDA) granted priority review in July 2015 for regular approval of the Tafinlar and Mekinist combination in BRAF V600 mutation-positive metastatic melanoma.