Novartis' Tafinlar/Mekinist combination approved in the EU for aggressive skin cancer

1 September 2015

Swiss drug major Novartis (VX: NOVN) has received approval from the European Commission for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) to treat adult patients with unresectable or metastatic melanoma with BRAF V600 mutation.

This makes it the first targeted combination approved in the European Union for this, the most aggressive form of skin cancer. It demonstrated improved overall survival against the current standard of care with BRAF inhibitor monotherapy in two Phase III studies. The COMBI-d study showed that the combination of Tafinlar and Mekinist achieved a statistically significant OS benefit compared to Tafinlar monotherapy (median of 25.1 months against 18.7 months.

Bruno Strigini, president of Novartis Oncology, said: "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. Today's EU approval further demonstrates our ongoing commitment to deliver medicines that can further enhance outcomes for patients with metastatic melanoma."

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