WASHINGTON -- The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) is now approved for treatment of unresectable or metastatic anaplastic thyroid cancer with the BRAF V600E mutation, the .
"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, the FDA's top official for oncology drugs, in a statement.
The dabrafenib-trametinib combination was previously approved for metastatic melanoma and non-small cell lung cancer with the same mutation.
Novartis, which manufactures both drugs and sponsored the trials leading to these approvals, says the, known as MAP-K.
The thyroid cancer approval was based on data from an open-label trial involving patients with a variety of rare BRAF-mutated tumors. Among 23 evaluable patients with thyroid cancers, 13 had partial responses and one had a complete response to the combination. Among those 14 patients, none had significant tumor growth for at least 6 months, the FDA said.
Both drugs come with lengthy lists of potentially severe side effects, as well as teratogenic risks that should be discussed with women of childbearing age.