FDA Approves Drug Combination for Treating BRAF-positive Anaplastic Thyroid Cancer – APhA submits compounding comments to FDA. – (866) 348-2889.
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.
The National Institutes of Health estimates there will be 53,990 new cases of thyroid cancer, and an estimated 2,060 deaths from the disease in the United States in 2018. Rare and aggressive, ATC accounts for about 1% to 2% of all thyroid cancers.