idecabtagene vicleucel

FDA Drug Profile — Abecma

Drug Details

Generic Name
idecabtagene vicleucel
Brand Names
Abecma
Application Number
BLA125736
Sponsor
Celgene Corporation
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
IDECABTAGENE VICLEUCEL

Indications and Usage

1 INDICATIONS AND USAGE ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ABECMA 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 after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ( 1 )