> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Ends Caprelsa REMS
- URL: https://www.fdaweb.com/fda-ends-caprelsa-rems/
- Published: 2025-09-25T12:00:00.000Z
- Updated: 2026-09-14T15:22:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159937

FDA says it has removed the REMS (Risk Evaluation and Mitigation Strategy) program for Sanofi’s thyroid cancer drug Caprelsa (vandetanib). An agency [notice](https://www.fda.gov/news-events/press-announcements/fda-removes-risk-evaluation-and-mitigation-strategies-rems-caprelsa-vandetanib?ref=fdaweb.com) 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.