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FDA Expands Sorafenib (Nexavar) Label to Include Treatment of Thyroid Cancer

Drug is already indicated for kidney and liver cancers (November 22)

The FDA has expanded the approved uses of sorafenib (Nexavar, Bayer HealthCare) to treat late-stage (metastatic) differentiated thyroid cancer.

The drug works by inhibiting multiple proteins in cancer cells, thereby limiting cancer cell growth and division. The newly approved use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.

The safety and effectiveness of sorafenib were established in a clinical study involving 417 participants with thyroid cancer. Sorafenib increased progression-free survival by 41% compared with placebo. Half of the patients treated with sorafenib lived without cancer progression for at least 10.8 months compared with at least 5.8 months in the placebo group.

The FDA approved sorafenib to treat advanced kidney cancer in 2005. In 2007, the agency expanded the drug’s label to treat liver cancer that cannot be surgically removed.

Source: FDA; November 22, 2013.

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