FDA Removes REMS Requirements for Vandetanib in Thyroid Cancer

The FDA has removed the risk evaluation and mitigation strategies (REMS) program for the thyroid cancer medication vandetanib (Caprelsa).¹

Vandetanib first became FDA-approved in 2011 for the treatment of medullary thyroid cancer in patients who had metastatic or unresectable disease. At the time of approval, a REMS program was put in place for heart rhythm monitoring and safe use due to the agent’s ability to cause QT prolongation. Mandatory training for health care professionals was also included in the REMS program.

After this time of oversight, no cases of torsades de pointes, a polymorphic ventricular tachycardia, or unexplained sudden deaths of patients taking vandetanib have been reported, and clinical data have not shown 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, MD, director of the FDA Oncology Center of Excellence, in a press release. “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.”

A long-term safety and efficacy analysis of 76 patients taking vandetanib for medullary thyroid cancer was published in 2021.² After 48 months of treatment with vandetanib, renal failure occurred in 2 patients and heart failure, cholecystitis, acute pancreatitis, posterior encephalopathy, and skin cancer were reported in 1 patient each.

REFERENCES:

1. FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib). News release. US FDA. September 25, 2025. Accessed September 25, 2025. https://tinyurl.com/zshdmjxk

2. Ramos HE, Hecht F, Berdelou A, et al. Long-term follow-up and safety of vandetanib for advanced medullary thyroid cancer. Endocrine. 2021 Feb;71(2):434-442. doi: 10.1007/s12020-020-02426-x. Epub 2020 Jul 20.