The FDA approved the expanded use of Nexavar (sorafenib; Bayer HealthCare and Onyx) for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.

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Nexavar is an oral multi-kinase inhibitor currently approved for the treatment of patients with unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

The safety and effectiveness of Nexavar were established in a clinical trial involving 417 participants with locally recurrent or metastatic, progressive differentiated thyroid cancer that does not respond to radioactive iodine treatment. 

Treatment with Nexavar increased the length progression-free survival by 41%. Half of patients receiving Nexavar lived without cancer progression for at least 10.8 months vs. at least 5.8 months for patients receiving placebo.

Nexavar was granted Priority Review by the FDA in August 2013.

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