Teclistamab (Tecvayli)

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

• 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)

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