Saturday, November 23, 2013
SILVER SPRING, Md. -- The FDA approved an expanded indication for the targeted cancer drug sorafenib (Nexavar) to treat metastatic, differentiated thyroid cancer.
A study reported earlier this year at the American Society of Clinical Oncology annual meeting was the main basis for approval. In it, sorafenib extended progression-free survival to a median 10.8 months compared with 5.8 months with placebo (P<0.0001). "Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement announcing the approval.
Sorafenib is currently approved for treating advanced kidney cancer and unresectable liver cancer.
Common side effects include diarrhea, infection, fatigue, alopecia, hand-foot syndrome, erythema, weight loss, anorexia, high blood pressure, and gastrointestinal complaints.
Also, patients on the drug may show increases in thyroid stimulating hormone, which may necessitate adjustment of thyroid hormone replacement doses, the FDA said.
( Source by: medpagetoday.com )