FDA Approves Dabrafenib plus Trametinib for Anaplastic Thyroid Cancer with BRAF V600E Mutation

May 4, 2018

On May 4, 2018, the Food and Drug Administration approved dabrafenib (TAFINLAR®, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST®, Novartis Pharmaceuticals Corp.) in combination for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Approval was based on a nine-cohort, non-randomized trial, BRF117019 (NCT02034110) enrolling patients with rare cancers with the BRAF V600E mutation, including locally advanced, unresectable, or metastatic ATC with no locoregional treatment options. The overall response rate was 61% (95% CI: 39%, 80%) in 23 patients with ATC who were evaluable for response. The complete and partial response rates were 4% and 57%, respectively. Response duration was at least 6 months in 64% of responding patients.

The adverse reaction profile among all patients in the trial and among patients in the ATC cohort was similar to that observed in other approved indications.

The recommended doses for ATC are 150 mg of dabrafenib orally twice daily and 2 mg of trametinib orally once daily. Full prescribing information is available at:

FDA granted this application priority review. FDA also granted breakthrough designation and orphan drug designation for the combination of dabrafenib and trametinib in the anaplastic thyroid cancer with BRAF V600 mutation indication. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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