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FDA Approves Two Drugs for Treatment of BRAF-Positive Anaplastic Thyroid Cancer

Thursday, May 10, 2018   (0 Comments)
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Two drugs, to be administered together for the treatment of anaplastic thyroid cancer (ATC) that cannot be surgically removed or has spread to other parts of the body and has a type of abnormal gene, BRAF V600E, Tafinlar (dabrafenib) and Mekinist (trametinib), have been approved by the US Food and Drug Adminsitration (FDA).

“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,” said Dr Richard Pazdur, 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. “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 also approved — for use or in combination — to treat BRAF V600 mutation-positive metastatic melanoma. Additionally, they have been approved for use in combination to treat BRAF V600E mutation-positive, metastatic non-small cell lung cancer.

The efficacy of the combination therapy in treating ATC was demonstrated in an open-label clinical trial of patients with rare cancers with the BRAF V600E mutation. Data from trials in BRAF V600E mutation-positive, metastatic melanoma or lung cancer and results in other BRAF V600E mutation-positive rare cancers provided confidence in the results seen in patients with ATC.

The FDA granted this approval to Novartis Pharmaceuticals Corporation.


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