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European Commission Approves Novartis’s Tafinlar/Mekinist Combo

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Novartis’s Tafinlar and Mekinist

Novartis (NVS) announced on August 29 that the European Commission had approved the combination of its drugs Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of patients with stage III BRAF V600 mutation-positive melanoma.

This was the third approval in Europe for the Tafinlar and Mekinist combination for the treatment of various tumor types. The approval was based on the results of the COMBI-AD study. Let’s discuss the details of the drug combination and the study.

The chart above shows the details of the approval of the Tafinlar and Mekinist combination.

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About Tafinlar and Mekinist

The Tafinlar and Mekinist combination has been approved for the treatment of various forms of tumors:

  • Approved in the United States, the European Union, Australia, Japan, Canada, and a few other countries for the treatment of unresectable or metastatic melanoma in patients with BRAF V600 mutations
  • Approved in the United States for the treatment of metastatic non-small cell lung cancer with a BRAF V600E mutation
  • Approved in the European Union for the treatment of advanced non-small cell lung cancer with a BRAF V600E mutation
  • Adjuvant treatment for post-resection V600E/K+ melanoma involving lymph nodes

About the COMBI-AD study

The COMBI-AD study evaluated the combination of Tafinlar and Mekinist in the treatment of patients with stage III BRAF V600E/K+ mutation-positive melanoma. The study included 438 patients who received a Tafinlar 150 mg BID and Mekinist 2 mg QD combination and another 432 patients who received a similar placebo.

The study’s primary endpoint was met in the primary analysis with a median follow-up of 2.8 years. The study showed that the Tafinlar and Mekinist combination reduced the risk of recurrence or death by ~53% compared to the placebo.

The First Trust Value Line Dividend ETF (FVD) holds 0.5% in Novartis, 0.5% in Sanofi (SNY), 0.5% in Amgen (AMGN), and 0.5% in Johnson & Johnson (JNJ).

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