You are here

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.

Recent Headlines

Triggers the Body’s Own Natural Blood Flow Regulation
Inrebic Reduces Symptoms by 50% in Some Patients
Novel Catheter-based Technology for Treating Acute Ischemic Stroke
Decision supported by data from more than 4,000 patients
Statistically Significant Improvement in Excessive Daytime Sleepiness
Researcher Made Himself Guinea Pig to Test the Drug
Treatment Shorter, Less Complicated Than Typical Regimen
Zip Device Faster to Apply, Minimizes Scarring