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Patient Education: Ciltacabtagene Autoleucel - Carvykti - (CART Cell Therapy) - Immunotherapy

Updated: Mar 27, 2022

Patient Education: Ciltacabtagene Autoleucel

CILTA CEL CART Cell therapy Multiple Myeloma

Ciltacabtagene Autoleucel ( Carvykti)

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

On February 28, 2022, the Food and Drug Administration approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

Safety and efficacy were evaluated in CARTITUDE-1 (NCT03548207), an open label, multicenter clinical trial evaluating ciltacabtagene autoleucel in 97 patients with relapsed or refractory multiple myeloma who received at least three prior lines of therapy which included a PI, an IMiD, and an anti-CD38 monoclonal antibody and who had disease progression on or after the last chemotherapy regimen; 82% had received four or more prior lines of antimyeloma therapy.

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References CARVYKTI- ciltacabtagene autoleucel injection, suspension:

FDA Label Prescribing Information (Revised 03/2022)

Prescribing Information | CARVYKTI

Medication Guide

Drug Label Information at DAILYMED - NIH-National Library of Medicine

DailyMed - CARVYKTI- ciltacabtagene autoleucel injection, suspension

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