FDA Approves Expanded Uses for Nexavar

25-Nov-13 8:00 AM  CST  

The Food and Drug Administration (FDA) has approved Nexavar (sorafenib) for the treatment of late stage differentiated thyroid cancer.  According to the National Cancer Institute approximately 60,220 individuals in the United States will be diagnosed with thyroid cancer and 1,850 will unfortunately die from the disease this year.  Nexavar works by inhibiting multiple proteins in the thyroid cancer cells which in turn limits the cancer’s cell growth and division. 

            According to the FDA, the most common side effects associated with Nexavar are diarrhea, fatigue, infection, hair loss, rashes, weight loss, decrease in appetite, nausea, high blood pressure, and abdominal pain. 

            Richard Pazdur, M.D., and Director of the Office of Hematology and Oncology Products of the FDA’s Center for Evaluation and Research recently commented on the new drug approval.  “Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies.  Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult to treat diseases,” said Pazdur. 

            Nexavar was first approved for advanced kidney cancer in 2005 and approved in 2007 for liver cancer.  It is co-marketed by Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals. 

1.  Goodin, Tara.  “FDA Approves Nexavar to Treat Type of Thyroid Cancer.”  FDA.  Web.  22 Nov 2013.  

2.  Medscpae Reports.  “FDA’s Oks Sorafenib for Advanced Thyroid Cancer.”  Medscape.  Web.  Date of Access:  24 Nov 2013. 

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Source: Jennifer S. O?Reilly

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