FDA - Food and Drug Administration
09/25/2025 | Press release | Distributed by Public on 09/25/2025 12:57
September 25, 2025 - FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
For Immediate Release: September 25, 2025
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.
"Cancer specialists now have adequate knowledge about managing the heart rhythm related risks of this medication," said Richard Pazdur, M.D., FDA Oncology Center of Excellence Director. "Health care providers have incorporated proper safety monitoring into their standard practice, making the formal requirements unnecessary. The mandatory monitoring program has achieved its goals."
Caprelsa will remain available with the same prescribing information, but health care providers will no longer need special certification or extra monitoring beyond standard clinical care.
A REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The safety requirements for Caprelsa included mandatory training for health care providers and monitoring of patients.
Contact Information:
- Health care providers, pharmacies, and patients with questions may contact the FDA at (855) 543-3784 or (301) 796-3400, or by email at [email protected].
- Adverse events, medication errors, or quality problems with Caprelsa should be reported to FDA's MedWatch Adverse Event Reporting program.
- FDA's top priority is patient safety, and the agency will continue to monitor the safety of this medication.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
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