Dabrafenib-Trametinib Combination Approved for Mutation-Positive Thyroid Cancer
FDA approval was based on results from a phase 2 clinical study assessing the efficacy of the combination treatment among patients with advanced or metastatic rare cancers.
The US Food and Drug Administration (FDA) approved dabrafenib and trametinib combination therapy for the treatment of patients with unresectable and metastatic BRAF V600E mutation-positive anaplastic thyroid cancer (ATC), according to a FDA news release.
The combination is the first FDA-approved treatment for ATC; the dabrafenib and trametinib combination had been previously approved for BRAF V600 mutation positive metastatic melanoma and non-small cell lung cancer.
The FDA based its approval on results from an open-label, phase 2 clinical study assessing the efficacy of the combination treatment among patients with advanced or metastatic rare cancers who had no standard-of-care options available. Study participants received dabrafenib 150 mg twice daily and trametinib 2 mg once daily until unacceptable toxicity, disease progression, or death.
Of 23 evaluable patients, 4% and 57% achieved a complete or partial response, respectively. Of the 14 patients who had a response, 64% (9 patients) did not have significant tumor growth for 6 months or longer.
The side effect profile of dabrafenib and trametinib in combination was consistent with those previously reported. Commonly reported adverse effects include fever, rash, arthralgia, myalgia, nausea, vomiting, diarrhea, decreased appetite, dyspnea, and hypertension.
ReferenceFDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer [news release]. Silver Spring, MD: US Food and Drug Administration; Updated May 4, 2017.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm606686.htm?utm_campaign=05042018_PR_FDA%20approves%20new%20uses%20for%202%20drugs%20for%20BRAF%20positive%20patients&utm_medium=email&utm_source=Eloqua. Accessed May 7, 2018.