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FDA Approves Bayer/Onyx Drug for Common Thyroid Cancer

Update Date: Nov 23, 2013 11:58 AM EST

The U.S. Food and Drug Administration (FDA) has approved the use of anti-cancer drug Nexavar (sorafenib) for late-stage differentiated thyroid cancer. The type is one of the most common kinds of thyroid cancer.

According to National Cancer Institute (NCI), around 60,220 people in United States alone will be diagnosed with the differentiated thyroid cancer and among those, nearly 1,850 will die in 2013.

“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research 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.”

Before approving the drug, extensive tests were carried out which involved 417 participants. During the use of Nexavar, patients’ time lived without the progression of cancer increased by 41 percent.

However, there were common side effects of Nexavar that the participants reported. These included diarrhea, fatigue, infection, hair loss (alopecia), hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains and high blood pressure (hypertension).

The drug Nexavar (sorafenib) is manufactured by Germany’s Bayer AG and Onyx Pharmaceuticals. Its use has already been approved in the treatment of advanced kidney and liver cancer. Amgen Inc acquired Onyx earlier this year.

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