Dabrafenib and Trametinib Receive FDA Approval for Anaplastic Thyroid Cancer
On 4 May 2018, the United States Food and Drug Administration (FDA) approved treatment for BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer with no locoregional treatment options, using dabrafenib (Tafinlar) and trametinib (Mekinist) together.
Approval was based on BRF117019, a nine-cohort, nonrandomized study including patients with BRAF V600E-mutated, locally advanced unresectable or metastatic anaplastic thyroid cancer without locoregional options—a clinical trial .
Among 23 evaluable patients with anaplastic thyroid cancer, the overall response rate was 61%. Complete and partial response rates were 4% and 57%, respectively. Response duration was at least 6 months in 64% of responders.
The following, seen in at least 20% of patients receiving this combination, side effectswere fever, lethargy, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia and myalgia .
For patients with anaplastic thyroid cancer, the recommended doses are oral dabrafenib 150 mg twice daily and trametinib 2 mg once daily.
Sources
fda.gov
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