Nexavar® (sorafenib) FDA-approved for Differentiated Thyroid Cancer

Written by Susan Spinasanta

The US Food and Drug Administration (FDA) announced approval of sorafenib (Nexavar® tablets, Bayer Healthcare Pharmaceuticals Inc., Wayne, NJ) for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine (RAI) treatment. Sorafenib was previously approved to treat hepatocellular carcinoma and advanced renal cell carcinoma.

The safety and effectiveness of sorafenib was established in a multicenter, randomized, double-blind, placebo-controlled clinical study involving 417 patients with locally recurrent or metastatic, progressive DTC refractory to RAI treatment. Progression-free survival was the primary efficacy outcome measure determined by a blinded independent radiological review. Other efficacy outcome measures included overall survival, tumor response rate, and duration of response.

Patients were randomized to receive sorafenib 400 mg twice daily (n=207) or placebo (n=210). Forty-eight percent of the patients were male, median age was 63 years, 62% had an Eastern Cooperative Oncology Group performance status of 0, and 99% had undergone thyroidectomy.

The most common side effects in patients treated with sorafenib were alopecia, decreased appetite, diarrhea, fatigue, gastrointestinal and abdominal pain, hand-foot skin reaction, hypertension, infection, nausea, rash, and weight loss.

November 25, 2013

Sources

FDA approves Nexavar to treat type of thyroid cancer. FDA News Release. November 22, 2013.

Nexavar® (sorafenib) Full Prescribing Information. http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf. Accessed November 25, 2013.

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