FDA Approves Nexavar for Advanced Thyroid Cancer

Nexavar approved to treat advanced differentiated thyroid cancer

/ Author:  / Reviewed by: Robert Carlson, M.D Beth Bolt, RPh

(RxWiki News) Thankfully, most thyroid cancers are treatable. However, when thyroid cancer comes back after treatment or spreads to other areas of the body, the disease is harder to treat.

Patients with advanced differentiated thyroid cancer now have a new treatment option.

The US Food and Drug Administration has approved oral Nexavar (sorafenib) tablets to treat locally recurrent (returned) or metastatic (has spread), progressive differentiated thyroid carcinoma that no longer responds to standard radioactive iodine treatment.

Differentiated thyroid cancers make up 94 percent of all thyroid cancers, which will be diagnosed in just 60,200 Americans this year. Papillary, follicular, and Heurhle cell types of thyroid cancer are “differentiated thyroid cancer.”

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The thyroid gland, located in the neck, releases hormones to control metabolism and a number of other functions of the body.

Nexavar, which is approved to treat other forms of cancer, works by blocking cancer cell growth and division. 

The medication was approved under the FDA’s priority review program, which provides an expedited six-month review for medicines that offer significant improvement in treating, preventing, or diagnosing serious illness.

"Nexavar is the first and only FDA-approved therapy for this type of thyroid cancer and is a positive development for patients who previously had limited treatment options," Pamela A. Cyrus, MD, Vice President and Head of US Medical Affairs, Bayer HealthCare Pharmaceuticals, said in a prepared statement.

The FDA approval is based on findings from the DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, which demonstrated Nexavar’s ability to extend the time during which the cancer does not progress — otherwise known as progression-free survival (PFS).

The trial involved 417 patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory (does not respond) to radioactive iodine treatment who were randomly assigned to receive 400 mg of oral sorafenib twice daily (207 patients) or a placebo (sugar pill, 210 patients).

Patients taking Nexavar had nearly double the PFS of those taking a placebo. Treated patients had a median PFS of 10.8 months compared to 5.8 months among patients taking placebo.

The most common side effects in patients taking Nexavar were weight loss, decreased appetite, abdominal pains, high blood pressure, diarrhea, infection, fatigue, hair loss, and hand-foot syndrome (redness, swelling, and pain on palms of hands and soles of feet).

The FDA approved Nexavar to treat advanced kidney cancer in 2005. The FDA expanded the drug's use in 2007 to treat liver cancer that cannot be surgically removed. 

The price of 30 tablets of Nexavar 200mg is $2,600. Participants in the DECISION trial took 400 mg of Nexavar twice daily, which is the approved dosage for treating advanced thyroid cancer. The manufacturers of Nexavar offer assistance to eligible patients unable to pay for their medication.

Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals.

Review Date: 
November 23, 2013
Last Updated:
January 2, 2014