CARVYKTI

STN:125746 
Proper Name: ciltacabtagene autoleucel
Tradename: CARVYKTI
Manufacturer: Janssen Biotech, Inc.
Indications: 

• Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.

Product Information

• Package Insert and Medication Guide - CARVYKTI

Latest Safety Information

• FDA approves labeling changes that include a Boxed Warning for Immune Effector Cell-associated Enterocolitis following treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
  October 10, 2025

Supporting Documents

• October 10, 2025 Approval Letter - CARVYKTI
• June 26, 2025 Approval Letter - CARVYKTI
• April 5, 2024 Clinical Review - CARVYKTI
• April 5, 2024 Approval Letter - CARVYKTI
• April 5, 2024 Statistical Review - CARVYKTI
• December 21, 2023 Approval Letter - CARVYKTI
• February 22, 2023 Approval Letter - CARVYKTI
• February 28, 2022 Approval Letter - CARVYKTI
• February 28, 2022 Summary Basis for Regulatory Action - CARVYKTI
• Approved Risk Evaluation and Mitigation Strategies (REMS) - CARVYKTI
• Approval History, Letters, Reviews, and Related Documents - CARVYKTI