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Novartis receives EU approval for combination treatment of metastatic melanoma

Novartis has received European Commission approval for the combination of Tafinlar and Mekinist to treat metastatic melanoma with a BRAF V600 mutation, according to a company release.

“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," Bruno Strigini, president of Novartis Oncology, said in the release. “Today's E.U. approval further demonstrates our ongoing commitment to deliver medicines that can further enhance outcomes for patients with metastatic melanoma.”

Marketing authorization was based on results from the Phase 3 COMBI-d and COMBI-v studies, in which the combination showed significant overall survival benefit vs. Tafinlar (dabrafenib) and Zelboraf (vemurafenib, Genentech) monotherapies, the release said.

The FDA also granted priority review for regular approval of the Tafinlar and Mekinist (trametinib) combination in July 2015, the release said.