Difference between revisions of "Ciltacabtagene autoleucel (Carvykti)"
m |
m |
||
| Line 2: | Line 2: | ||
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== | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
| Line 22: | Line 25: | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| + | [[Category:REMS program]] | ||
[[Category:FDA approved in 2022]] | [[Category:FDA approved in 2022]] | ||
Revision as of 00:55, 20 May 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
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)
Also known as
- Code names: JNJ-68284528, LCAR-B38M
- Generic name: cilta-cel
- Brand name: Carvykti