The U.S. Food and Drug Administration (FDA) has 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) who have a BRAF V600E mutation and have no satisfactory local treatment options.
The approval was based on a 9-cohort, non-randomized trial, BRF117019 (NCT02034110), which enrolled patients with rare cancers harboring BRAF V600E mutations, including locally advanced, unresectable, or metastatic ATC with no local treatment options. In 23 patients with ATC, the overall response rate was 61% (95% CI: 39%, 80%), with an evaluable response. The complete response rate was 4%, and the partial response rate was 57%. 64% of responding patients had a duration of response of at least 6 months.
Adverse events in all patients in the trial and in the ATC cohort were similar to those observed in other approved indications.
The recommended dosage for ATC is 150 mg dabrafenib twice daily orally and 2 mg trametinib once daily orally.
How should I store MEKINIST?
Store MEKINIST in a refrigerator at 36°F to 46°F (2°C to 8°C).
Keep MEKINIST dry, away from moisture and light.
The MEKINIST bottle comes with a desiccant packet to help keep the medication dry. Do not discard the desiccant packet.
Keep MEKINIST in its original bottle. Do not keep the tablets in the pillbox.
Safely discard expired or no longer needed MEKINIST.
Keep MEKINIST and all medications out of the reach of children.
Unopened bottles have a shelf life of 2 years; opened bottles have a shelf life of 30 days at temperatures not exceeding 30°C.
