US FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
United States, Sept. 25 -- The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Genzyme Corporation (now Sanofi).The FDA first approved Caprelsa in 2011 to treat medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed. At the time, a REMS program was required to ensure appropriate heart rhythm monitoring and safe use. After over more than a decade of oversight, REMS assessments reported no cases of Torsades de pointes or unexplained sudden deaths among U.S. patients taking Caprelsa. Clinical data also showed no concerning patterns of heart rhythm problems. Caprelsa will rema...
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