On September 25, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) program for vandetanib, according to an announcement from the agency.
Vandetanib is a tyrosine kinase inhibitor targeting VEGFR, EGFR, and RET from manufacturer Sanofi (formerly Genzyme Corporation). The agent was first approved by the FDA in 2011 for the treatment of patients with medullary thyroid cancer with disease progression or whose disease cannot be removed surgically. The approval came along with a requirement for a REMS program to ensure appropriate monitoring of hearth rhythm, focusing on QT prolongation, to reduce the risk for torsades de pointes and sudden death. The REMS safety program was instated to ensure that the benefits of the agent outweighed its risks. The program for vandetanib also required training for health-care professionals.
After more than a decade of the program, there were no reported cases of Torsades de pointes or unexplained sudden deaths among patients in the United States taking vandetanib. Clinical data did not show any concerning signs of heart rhythm problems either.
“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. “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.”
Going forward, vandetanib will have the same prescribing information but no extra monitoring will be needed beyond standard clinical care.
