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 one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
Product Information
Supporting Documents
- 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