Risk Evaluation and Mitigation Strategy

On June 26, 2025, the FDA approved the removal of the REMS requirement for Kymriah. REMS is no longer necessary to ensure that the benefits of Kymriah outweigh its risks and to minimize the burden on the healthcare delivery system of complying with the REMS.

The FDA determined that the goal of the REMS and the elements to assure safe use are no longer necessary to ensure that the benefits of Kymriah outweigh its risks. The established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing the risks of cytokine release syndrome (CRS) and neurological toxicities has shown that the safe and effective use of Kymriah for the indicated population can be assured without a REMS. The risks for Kymriah can be conveyed adequately via the current product labeling including the Medication Guide which is a part of the approved labeling. Additionally, adverse event reporting for CRS and neurological toxicities have remained stable and the adverse event reporting requirements are adequate for continued routine safety monitoring of Kymriah.

Hospitals will still need to continue to be contracted with Novartis Pharmaceuticals to obtain Kymriah.

Hospitals will no longer need to designate an Authorized Representative.

REMS audits will no longer need to be conducted.

Although the REMS is lifted, Novartis can still supply your institution with a patient safety wallet card that outlines signs and symptoms of cytokine release syndrome and neurological toxicities that patients should be aware of and when to seek medical attention should they experience them.

Please refer to the US PI to manage risks associated with Kymriah treatment.

For more information on the Kymriah REMS release, please feel free to call:

• FDA
  Main FDA for general inquiries

  • 1-888-INFO-FDA (1-888-463-6332)

  Drug Information:

  • 301-796-3400 (8:00 AM - 4:30 PM Eastern Time)

  E-mail:

  • [email protected]

• Novartis Medical Information

  • 1-888-NOW-NOVA (1-888-669-6682)

Please refer to the Kymriah product website for more information on Kymriah treatment:

For HCPs: https://www.kymriah-hcp.com

For Patients: https://us.kymriah.com

Please report adverse events to:

Online Web Portal Novartis Adverse Event Reporting Online

Email: [email protected]