Difference between revisions of "Idecabtagene vicleucel (Abecma)"
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==Mechanism of action== | ==Mechanism of action== | ||
| − | + | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/idecabtagene-vicleucel NCI Drug Dictionary]: A preparation of autologous peripheral blood T lymphocytes (PBTLs) that have been genetically modified to express a chimeric antigen receptor (CAR) specific for the B-cell maturation antigen (BCMA), with potential immunostimulating and antineoplastic activities. Upon administration, idecabtagene vicleucel specifically recognizes and kills BCMA-expressing tumor cells. | |
| + | |||
| + | ==Toxicity management== | ||
| + | *[https://www.abecmarems.com Link to REMS program] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Multiple myeloma]] | *[[Multiple myeloma]] | ||
| − | |||
| − | |||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2021-03-26: Approved for the treatment of adult patients with relapsed or refractory [[multiple myeloma]] after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ''(Based on KarMMa)'' |
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2021-08-25: Initial conditional authorization for the treatment of adult patients with relapsed and refractory [[multiple myeloma]] who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy. ''(Based on KarMMa)'' | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-05-26: Initial notice of compliance with conditions for the treatment of adult patients with [[multiple myeloma]] who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2022-01-20: Initial approval | ||
| + | ==Patient Drug Information== | ||
| + | *[https://www.fda.gov/media/147055/download idecabtagene vicleucel (Abecma) Package Insert]<ref>[https://www.fda.gov/media/147055/download idecabtagene vicleucel (Abecma) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
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*'''Brand name:''' Abecma | *'''Brand name:''' Abecma | ||
| − | [[Category: | + | ==References== |
| + | |||
| + | [[Category:Anti-BCMA CAR T-cells]] | ||
| + | [[Category:Anti-BCMA cellular therapy]] | ||
| + | |||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| + | [[Category:REMS program]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:PMDA approved in 2022]] | ||
Latest revision as of 15:34, 28 June 2023
Mechanism of action
From the NCI Drug Dictionary: A preparation of autologous peripheral blood T lymphocytes (PBTLs) that have been genetically modified to express a chimeric antigen receptor (CAR) specific for the B-cell maturation antigen (BCMA), with potential immunostimulating and antineoplastic activities. Upon administration, idecabtagene vicleucel specifically recognizes and kills BCMA-expressing tumor cells.
Toxicity management
Diseases for which it is used
History of changes in FDA indication
- 2021-03-26: Approved for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. (Based on KarMMa)
History of changes in EMA indication
- 2021-08-25: Initial conditional authorization for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy. (Based on KarMMa)
History of changes in Health Canada indication
- 2021-05-26: Initial notice of compliance with conditions for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment.
History of changes in PMDA indication
- 2022-01-20: Initial approval
Patient Drug Information
Also known as
- Code name: bb2121
- Generic name: ide-cel
- Brand name: Abecma