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Novartis Says EU Approves Tafinlar In Combination With Mekinist


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(RTTNews.com) - Novartis ( NVS ) said that the European Commission has approved Tafinlar or dabrafenib in combination with Mekinist or trametinib for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection.

The approval is the third for Tafinlar in combination with Mekinist in Europe across a variety of tumor types identified with a high level of BRAF mutation. It also demonstrates Novartis leadership in BRAF+ targeted therapy, and to date, more than 60,000 patients worldwide have been treated with the combination therapy across four indications.


The approval is based on results from the Phase III COMBI-AD global study, which
enrolled more than 870 patients with stage III, BRAF V600E/K-mutant melanoma
without prior anticancer therapy, and who were randomized within 12 weeks of
complete surgical resection. Patients received the Tafinlar (150 mg BID) +
Mekinist (2 mg QD) combination (n = 438) or matching placebos (n = 432).

In the primary analysis, and after a median follow-up of 2.8 years, the primary
endpoint was met, with the combination therapy significantly reducing the risk
of disease recurrence or death by 53% vs. placebo.

Based on updated data, with an additional 10 months of follow-up compared to the primary analysis (minimum follow-up of 40 months), treatment with the combination therapy reduced the risk of recurrence or death by 51% vs. placebo.

In addition, the relapse free survival (RFS) benefit among the combination arm was observed across all patient subgroups, including stage III A, B and C. The combination treatment group also saw an improvement in a key secondary endpoint of overall survival.


Read the original article on RTTNews (http://www.rttnews.com/2930197/novartis-says-eu-approves-tafinlar-in-combination-with-mekinist.aspx)


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Referenced Symbols: NVS



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