Difference between revisions of "Idecabtagene vicleucel (Abecma)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *3/26/2021: 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. ''( | + | *3/26/2021: 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)'' |
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| + | ==History of changes in EMA indication== | ||
| + | *8/25/2021: 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)'' | ||
==Patient Drug Information== | ==Patient Drug Information== | ||
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[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
[[Category:REMS program]] | [[Category:REMS program]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
Revision as of 12:47, 30 December 2022
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
- 3/26/2021: 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
- 8/25/2021: 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)
Patient Drug Information
Also known as
- Code name: bb2121
- Generic name: ide-cel
- Brand name: Abecma