FDA Approves Combo Therapy for BRAF-Positive Anaplastic Thyroid Cancer

The combination therapy dabrafenib plus trametinib approved for the treatment of BRAF V600 mutation-positive anaplastic thyroid cancer that cannot be removed by surgery or is metastatic.

Officials with the FDA have approved Novartis’ combination treatment dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of BRAF V600 mutation-positive anaplastic thyroid cancer (ATC) that cannot be removed by surgery or is metastatic, according to a press release.

Earlier this week, the combination therapy received approval for adjuvant use in BRAF V600-mutant melanoma following complete surgical resection. Dabrafenib plus trametinib are also approved to treat BRAF V600-mutation-positive, metastatic non-small cell lung cancer.

“This is the first FDA-approved treatment for patients with this aggressive form of thyroid cancer, and the third cancer with this specific gene mutation that this drug combination has been approved to treat,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This approval demonstrates that targeting the same molecular pathway in diverse diseases is an effective way to expedite the development of treatments that may help more patients.”

The approval is based on a clinical trial demonstrating the combination therapy’s efficacy in treating ATC among patients with rare cancers with the BRAF V600E mutation. Of 23 evaluable patients in the trial, 57% experienced a partial response and 4% experienced a complete response to the treatment. In 9 of 14 patients with responses, there were no significant tumor growths for 6 months or longer.

Adverse effects associated with the therapy in patients with ATC were shown to be consistent with those seen in other cancers. Common adverse events include fever, rash, chills, headache, joint pain, cough, fatigue, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, high blood pressure, and difficulty breathing.


FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer [news release]. FDA’s website. 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 4, 2018.

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