Difference between revisions of "Ciltacabtagene autoleucel (Carvykti)"
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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ciltacabtagene-autoleucel 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. | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ciltacabtagene-autoleucel 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. | ||
| − | ==Diseases for which it is | + | ==Toxicity management== |
| + | *[https://carvyktirems.com/#Main Link to REMS program] | ||
| + | |||
| + | ==Diseases for which it is established ''(work in progress)''== | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
==History of changes in FDA indication== | ==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== | ==Also known as== | ||
*'''Code names:''' JNJ-68284528, LCAR-B38M | *'''Code names:''' JNJ-68284528, LCAR-B38M | ||
| Line 14: | Line 22: | ||
==References== | ==References== | ||
| + | [[Category:Anti-BCMA CAR T-cells]] | ||
| + | [[Category:Anti-BCMA cellular therapy]] | ||
| + | [[Category:Anti-CD137 cellular therapy]] | ||
| − | |||
| − | |||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| + | [[Category:REMS program]] | ||
| + | [[Category:EMA approved in 2022]] | ||
[[Category:FDA approved in 2022]] | [[Category:FDA approved in 2022]] | ||
| + | [[Category:Health Canada approved in 2023]] | ||
| + | [[Category:PMDA approved in 2022]] | ||
Latest revision as of 16:18, 1 January 2024
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