Difference between revisions of "Teclistamab (Tecvayli)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*10/25/2022: Approved for adult patients with relapsed or refractory [[multiple myeloma]] who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ''(Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)'' | *10/25/2022: Approved for adult patients with relapsed or refractory [[multiple myeloma]] who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. ''(Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *8/23/2022: Initial conditional approval | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' JNJ 64007957 | *'''Code name:''' JNJ 64007957 | ||
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[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
[[Category:REMS program]] | [[Category:REMS program]] | ||
| + | [[Category:EMA approved in 2022]] | ||
[[Category:FDA approved in 2022]] | [[Category:FDA approved in 2022]] | ||
Revision as of 02:24, 31 December 2022
General information
Class/mechanism from the NCI Drug Dictionary: A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17), a tumor-associated antigen (TAA) expressed on plasma cells, with potential antineoplastic activity. Upon administration, teclistamab binds to both CD3 on T cells and BCMA expressed on malignant plasma cells. This results in the cross-linking of T cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against BCMA-expressing plasma cells.
Route: IV
Extravasation: no information
Toxicity management
Diseases for which it is established
History of changes in FDA indication
- 10/25/2022: Approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. (Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)
History of changes in EMA indication
- 8/23/2022: Initial conditional approval
Also known as
- Code name: JNJ 64007957
- Generic name: teclistamab-cqyv
- Brand name: Tecvayli