ciltacabtagene autoleucel

FDA Drug Profile — CARVYKTI

Drug Details

Generic Name
ciltacabtagene autoleucel
Brand Names
CARVYKTI
Application Number
BLA125746
Sponsor
Janssen Biotech, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
CILTACABTAGENE AUTOLEUCEL

Indications and Usage

1 INDICATIONS AND USAGE CARVYKTI is indicated for the 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. CARVYKTI is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the 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. ( 1 )