Tuesday, November 26, 2013

FDA Expands Nexavar Label to Treat Late-Stage Thyroid Cancer

FDA Expands Nexavar Label to Treat Late-Stage Thyroid Cancer:
The US Food and Drug Administration issued a statement saying it has expanded the approved uses of the drug Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.
Differentiated thyroid cancer is the most common type of thyroid cancer; the National Cancer Institute's SEER statistics estimate that each year about 60,220 Americans will be diagnosed with thyroid cancer, and 1,850 will die from the disease.
Nexavar works by inhibiting multiple proteins in cancer cells, thereby limiting cancer cell growth and division.
The FDA initially approved Nexavar for the treatment of advanced kidney cancer in 2005. Two years later it expanded the drug’s label to treat unresectable liver cancer. Nexavar's new approved use is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.
Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research:
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.
A clinical trial involving 417 participants with locally recurrent or metastatic, progressive differentiated thyroid cancer that did not respond to radioactive iodine treatment established the drug's safety and effectiveness. The findings demonstrated that Nexavar could increase progression free survival (the length of time patients lived without the cancer progressing) by 41 percent. 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.
Source: FDA
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