Tecvayli FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2024.
FDA Approved: Yes (First approved October 25, 2022)
Brand name: Tecvayli
Generic name: teclistamab-cqyv
Dosage form: Injection
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of 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.
- This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Multiple myeloma is a cancer of the plasma cells in the bone marrow. Plasma cells normally make antibodies which fight infection, but when the plasma cells become malignant and develop into multiple myeloma, the myeloma cells proliferate and replace normal cells in the bone marrow.
- Tecvayli targets both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells. Tecvayli works by redirecting CD3-positive T-cells to BCMA-expressing myeloma cells to induce the killing of the cancer cells.
- Tecvayli is administered by subcutaneous injection.
- Warnings and precautions associated with Tecvayli include hepatotoxicity, infections, neutropenia, hypersensitivity and other administration reactions, and embryo-fetal toxicity.
- Common adverse reactions observed in clinical trials include cytokine release syndrome, neutropenia, and anemia. Infections were frequent with the most common being upper respiratory tract infections and pneumonia. Hypogammaglobinemia and neurotoxic events were also observed in some patients.
Development timeline for Tecvayli
Further information
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