Tafinlar + Mekinist Approved for BRAF-Positive Anaplastic Thyroid Cancer

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The FDA granted Priority Review and Breakthrough Therapy designation for this indication
The FDA granted Priority Review and Breakthrough Therapy designation for this indication

The Food and Drug Administration (FDA) has approved the combination Tafinlar (dabrafenib; Novartis) and Mekinist (trametinib; Novartis) for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body, and is BRAF V600E mutation-positive.

The approval for use in ATC was supported by data from an open-label clinical trial of patients with rare cancers with the BRAF V600E mutation. Study data showed 57% of evaluable patients (N=23) had a partial response and 4% achieved a complete response. Among the 14 responders, 64% did not have significant tumor growths for ≥6 months. 

"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 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. 

Tafinlar and Mekinist are also approved, as monotherapy or in combination, to treat BRAF V600 mutation-positive metastatic melanoma; the combination therapy is also indicated for BRAF V600E mutation-positive, metastatic, non-small cell lung cancer (NSCLC). 

Tafinlar is available as 50mg and 75mg capsules in 120-count bottles. Mekinist is available as 0.5mg and 2mg film-coated tablets in 30-count bottles.

For more information visit FDA.gov.

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