Drugs

FDA Ends Caprelsa REMS

FDA says it has removed the REMS (Risk Evaluation and Mitigation Strategy) program for Sanofi’s thyroid cancer drug Caprelsa (vandetanib). An agency notice says Caprelsa will remain available with the same prescribing information, but healthcare providers will no longer need special certification or extra monitoring beyond standard clinical care.

“Cancer specialists now have adequate knowledge about managing the heart rhythm-related risks of this medication,” FDA Oncology Center of Excellence director Richard Pazdur says. “Healthcare providers have incorporated proper safety monitoring into their standard practice, making the formal requirements unnecessary. The mandatory monitoring program has achieved its goals.”

Caprelsa was first approved by FDA in 2011 to treat medullary thyroid cancer in patients whose disease had spread or could not be surgically removed. At the time, a REMS program was required to ensure appropriate heart rhythm monitoring and safe use.

The agency says that 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 the drug. Clinical data also showed no concerning patterns of heart rhythm problems, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome