FDA ushers in Sorafenib for the treatment of metastatic thyroid cancer

Sorafenib, otherwise known as Nevaxar, is now approved to treat advanced thyroid cancer as of a Nov. 22 statement from the FDA.

The drug is indicated specifically for iodine-refractory differentiated thyroid cancer, a relatively infrequently diagnosed subtype affecting about 5 to 15 percent of thyroid cancer patients.

Produced by Bayer, sorafenib treats differentiated thyroid cancer by blocking the RAF kinase enzyme essential for cell division and angiogenesis and other signaling pathways. It is already approved as a therapy for advanced kidney and liver carcinomas, but the treatment is the first approved to treat differentiated thyroid cancer in decades.

“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases.”

Results of the phase III clinical trial to assess sorafenib’s safety and effectiveness for treating metastatic thyroid cancer (the DECISION study) were presented at the annual meeting of the American Society of Clinical Oncology in June. According to the data from 417 patients with radioactive iodine-refractory differentiated thyroid cancer, sorafenib extended progression-free survival by five months, to 10.8 months, compared to placebo.