Ciltacabtagene autoleucel (Carvykti)
Mechanism of action
From the NCI Drug Dictionary: A preparation of autologous T lymphocytes that are transduced, ex vivo, with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing two bispecific anti-B-cell maturation antigen (BCMA) variable fragments of llama heavy-chain murine antibodies fused to the signaling domain of 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. The antigen-binding region of the CAR is a non-scFv structure targeting two distinct regions of BCMA. Upon intravenous administration back into the patient, the autologous bi-epitope BCMA-targeted CAR T cells JNJ-68284528 are directed to cells expressing BCMA, bind to two different epitopes on BCMA and induce selective toxicity in BCMA-expressing tumor cells.
Toxicity management
Diseases for which it is established (work in progress)
History of changes in FDA indication
- 2022-02-28: Approved 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. (Based on CARTITUDE-1)
History of changes in EMA indication
- 2022-05-25: Initial conditional authorization
History of changes in Health Canada indication
- 2023-02-09: Initial notice of compliance with conditions for the treatment of adult patients with multiple myeloma, who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and who are refractory to their last treatment.
History of changes in PMDA indication
- 2022-02-26: Initial approval
Also known as
- Code names: JNJ-68284528, LCAR-B38M
- Generic name: cilta-cel
- Brand name: Carvykti