Difference between revisions of "Teclistamab (Tecvayli)"
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<br>Extravasation: no information | <br>Extravasation: no information | ||
| − | == | + | ==Toxicity management== |
| − | + | *[https://www.tec-talrems.com/ Link to REMS program] | |
| − | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Multiple myeloma]] | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *2022-10-25: 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)'' | ||
| + | *2024-02-20: Approved for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or refractory [[multiple myeloma]] who have achieved and maintained a complete response or better for a minimum of 6 months. ''(Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2022-08-23: Initial conditional approval as monotherapy 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. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' JNJ 64007957 | + | *'''Code name:''' JNJ-64007957 |
| − | *'''Generic name:''' teclistamab | + | *'''Generic name:''' teclistamab-cqyv |
| + | *'''Brand name:''' Tecvayli | ||
==References== | ==References== | ||
| Line 17: | Line 25: | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | + | [[Category:Anti-BCMA-CD3 bispecific antibodies]] | |
| − | [[Category:Anti-BCMA | ||
| − | |||
| − | |||
| − | |||
| − | [[Category: | + | [[Category:Multiple myeloma medications]] |
| + | [[Category:REMS program]] | ||
| + | [[Category:EMA approved in 2022]] | ||
| + | [[Category:FDA approved in 2022]] | ||
Latest revision as of 16:06, 3 March 2024
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
- 2022-10-25: 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)
- 2024-02-20: Approved for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a complete response or better for a minimum of 6 months. (Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)
History of changes in EMA indication
- 2022-08-23: Initial conditional approval as monotherapy 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.
Also known as
- Code name: JNJ-64007957
- Generic name: teclistamab-cqyv
- Brand name: Tecvayli