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FDA approves Nexavar for differentiated thyroid cancer
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The FDA today approved sorafenib for the treatment of patients with metastatic differentiated thyroid cancer.
“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases.”
Richard Pazdur
The FDA approved sorafenib (Nexavar, Bayer Healthcare) — an oral multikinase inhibitor — under its priority review program.
The approval was based in part on results of a trial that included 417 patients with locally recurrent or metastatic, progressive differentiated thyroid cancer unresponsive to treatment with radioactive iodine.
Results showed sorafenib extended PFS by 41%.
Fifty percent of patients assigned to sorafenib experienced at least 10.8 month PFS vs. 5.8 month PFS in patients assigned to placebo.
Diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains and hypertension were the most common adverse events associated with sorafenib.
Researchers found that elevation of thyroid-stimulating hormone — a potential promoter of thyroid cancer — was common with sorafenib and may require adjustment of thyroid hormone replacement therapy.
The FDA approved sorafenib for the treatment of advanced kidney cancer in 2005. In 2007, the drug was also approved for inoperable liver cancer.