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FDA Approves Drug Combination for Anaplastic Thyroid Cancer
The US Food and Drug Administration (FDA) approved a drug combination for the treatment of anaplastic thyroid cancer.
Dabrafenib (Taflinar) and trametinib (Mekinist) are now approved in combination for the treatment of anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body and is BRAF V600E mutation-positive.
Dabrafenib and trametinib are already approved in combination for the treatment of BRAF V600E mutation-positive melanoma and metastatic non-small cell lung cancer.
This approval is based on results from an open-label clinical trial of patients with rare cancers with the BRAF V600E mutation. Among 23 evaluable patients, 57% experienced a partial response and 4% experienced a complete response after treatment with dabrafenib plus trametinib. Nine of the 14 patients with responses showed no significant tumor growths for 6 months or longer.
“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, in a press release (May 4, 2018). “ “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.”—Janelle Bradley
