The FDA ( Food and Drug Administration ) has expanded the approved uses of Nexavar ( Sorafenib ) to treat metastatic differentiated thyroid cancer.
Sorafenib 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.
The safety and effectiveness of Sorafenib 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.
Sorafenib has 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.
The most common side effects in patients treated with Nexavar were diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains and hypertension.
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.
The FDA completed its review of Nexavar’s new indication under its priority review program. This program provides for an expedited, six-month review for drugs that may offer a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious condition.
Nexavar also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.
The 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.
Thyroid cancer is a cancerous growth of the thyroid gland, which is located in the neck. Differentiated thyroid cancer is the most common type of thyroid cancer.
The National Cancer Institute ( NCI ) estimates that 60,220 Americans will be diagnosed with thyroid cancer and 1,850 will die from the disease in 2013. ( Xagena )
Source: FDA, 2013