FDA approves Nexavar to treat metastatic differentiated thyroid cancer

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

“The FDA approval to expand the indication of Nexavar to include treatment for late-stage [metastatic] differentiated thyroid cancer provides another therapeutic option that physicians can choose from when it comes to treating patients who are diagnoses with this more difficult to treat cancer type,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

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

Thyroid cancer is a cancerous growth of the thyroid gland. Differentiated thyroid cancer is the most common type of thyroid cancer. The National Cancer Institute estimates that 60,220 Americans will be diagnosed with thyroid cancer and 1,850 will die from the disease in 2013.

The safety and effectiveness of Nexavar were established in a clinical study involving 417 participants with locally recurrent or metastatic, progressive differentiated thyroid cancer that does not respond to radioactive iodine treatment. Nexavar increased the length of time patients lived without the cancer progressing (progression-free survival) by 41%. Half of patients receiving Nexavar lived without cancer progression for at least 10.8 months compared to at least 5.8 months for participants receiving a placebo.

Diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, and high blood pressure were the most common side effects in patients treated with Nexavar. Thyroid stimulating hormone, a potential promoter of thyroid cancer, is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone replacement therapy.

FDA completed its review of Nexavar’s new indication under its priority review program. FDA approved Nexavar 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.