Difference between revisions of "Ciltacabtagene autoleucel (Carvykti)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*2/28/2022: 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)'' | *2/28/2022: 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== | |
| + | *5/25/2022: Initial conditional authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' JNJ-68284528, LCAR-B38M | *'''Code names:''' JNJ-68284528, LCAR-B38M | ||
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[[Category:REMS program]] | [[Category:REMS program]] | ||
| + | [[Category:EMA approved in 2022]] | ||
[[Category:FDA approved in 2022]] | [[Category:FDA approved in 2022]] | ||
Revision as of 02:29, 31 December 2022
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
- 2/28/2022: 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
- 5/25/2022: Initial conditional authorization
Also known as
- Code names: JNJ-68284528, LCAR-B38M
- Generic name: cilta-cel
- Brand name: Carvykti