FDA Approves New Treatment for Rare Form of Thyroid Cancer

Effective cancer treatments always seem to be fewer than needed. In the case of thyroid cancer, however, the United States Food and Drug Aministration (FDA) recently approved two drugs as treatment. Tafinlar, and Mekinist represent a new option for thyroid cancer patients when administered together. Keep reading to learn more, or follow the original source here for additional details.

The new treatment option specifically targets anaplastic thyroid cancer. The FDA approves the treatment in cases where the cancer cannot be surgically excised, or the cancer spreads to other areas of the body. Anaplastic thyroid cancer is a rare, and especially aggressive form of thyroid cancer. It accounts for roughly one to two percent of all thyroid cancer cases in the United States.

This new treatment option stands as an FDA first.

While the combination of drugs effectively targets two other cancers with the same gene mutation (BRAF V600E), the combined treatment exists as the first FDA-approved option for anaplastic thyroid cancer. The approval of this treatment shows that focusing on matching molecular pathways across different diseases allows for increased effectiveness in treatment development.

An open-label clinical trail proved the efficacy of the Tafinlar and Mekinsit combination. Data from other trials, in which the combination tested against BRAF V600E mutation-positive metastatic melanoma, and lung cancer reinforced the results against anaplastic thyroid cancer.

The trial examined the overall response rate of patients. Reduction in tumor size served as the measure of effectiveness. Of 23 evaluable patients, over half showed a partial response. Four percent of patients experienced a complete response. Of the patient group showing a response (14), 64% showed no significant tumor growth during a period of six months or longer.

Side effects of the drug combination when treating anaplastic thyroid cancer proved consistent when compared to the drugs treating other cancers. Common side effects included fever, rash, chills, joint pain, nausea, myalgia, headache, edema, cough, fatigue, decrease in appetite, hypertension, and difficulty breathing.

Severe side effects included the development of new cancers, serious bleeding problems, inflammation of the intestines, severe problems with eyes, lungs, or breathing, and high blood pressure. Both drugs may cause harm to developing fetuses and the FDA advises women to be aware of the risk and take preventative measures. Click here for further information on each drug and its side effects.

The FDA additionally granted priority review, breakthrough therapy, and orphan drug status to the combined treatment for anaplastic thyroid cancer. The FDA granted these approvals to Novartis Pharmaceuticals Corporation for further development of treatment.

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