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

• Treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monclonal antibody.

Product Information

• Package Insert - CARVYKTI

Supporting Documents

• 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