Difference between revisions of "Idecabtagene vicleucel (Abecma)"
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==History of changes in Health Canada indication== | ==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. | *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== | ==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> | *[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> | ||
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==References== | ==References== | ||
| − | [[Category: | + | [[Category:Anti-BCMA CAR T-cells]] |
[[Category:Anti-BCMA cellular therapy]] | [[Category:Anti-BCMA cellular therapy]] | ||
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[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
[[Category:Health Canada 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