Tafinlar, Mekinist receive the go-ahead
Last week, the United States Food & Drug Administration approved dabrafenib (Tafinlar, Novartis) and trametinib (Mekinist, Novartis) as a combination therapy for anaplastic thyroid cancer (ATC).
“This is the first FDA-approved treatment for patients with this aggressive form of thyroid cancer,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
This same combination has been previously approved for treatment of BRAF-positive metastatic melanoma and non-small cell lung cancer.
“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,” said Pazdur.
ATC is a rather low-occurring form of thyroid cancer, accounting for only 1–2 of all cases (about 54,000 cases annually). The FDA reported encouraging data from trails with metastatic melanoma and non-small cell lung cancer.
Investigator in one recent trail reported out of 23 evaluable patients, 57 percent experienced a partial response and 4 percent experienced a complete response; in 9 (64 percent) of the 14 patients with responses, there were no significant tumor growths for 6 months or longer.