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Pharmaceuticals / Submissions and Approvals

Novartis’ Tafinlar + Mekinist Wins EU Approval

April 13, 2017
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The European Commission has approved Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) combination for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer.

The EU approval follows a positive opinion granted in February by the Committee for Medicinal Products for Human Use, which was based on safety and efficacy of dabrafenib in combination with trametinib in a Phase II, three-cohort, multicenter, non-randomized and open-label study.

The FDA granted Tafinlar and Mekinist breakthrough therapy designation for advanced or metastatic BRAF V600E-positive NSCLC patients in 2015 and priority review in November 2016.

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