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
Supporting Documents
- 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
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Content current as of:
06/26/2025
