FDA Approves Drug Combo for Aggressive Thyroid Cancer; Dabrafenib + trametinib approved to treat BRAF-positive anaplastic thyroid cancer.
MONDAY, May 7, 2018 (HealthDay News) -- Two anti-cancer drugs administered together have been approved by the U.S. Food and Drug Administration to treat BRAF-positive anaplastic thyroid cancer.
Tafinlar (dabrafenib) and Mekinist (trametinib) combined have been approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene, the agency said Friday in a news release. The same drug combination was approved previously to treat melanoma and non-small-cell lung cancer caused by abnormalities of the same gene.
Common side effects of the drug combination include: fever, rash, chills, headache, arthralgia, cough, fatigue, nausea, and diarrhea, the FDA said. More serious adverse reactions could include: development of new cancers, bleeding problems, heart problems, eye problems, skin reactions, high blood sugar, anemia, and blood clots. Since both drugs can harm a growing fetus, pregnant women and women who are expecting to become pregnant shouldn't take the therapy, the agency warned.
"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, M.D., 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 statement. "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."
Both drugs are produced by the Swiss drugmaker Novartis Pharmaceuticals.