TECVAYLI teclistamab

Drug Class

Bispecific BCMA-directed CD3 T-cell engager

Mechanism

Binds BCMA on myeloma cells and CD3 on T-cells, directing T-cells to execute immune-mediated cytolysis of myeloma cells.

Approved Indication

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.

What This Means For Patients

Tecvayli (teclistamab) is a bispecific monoclonal antibody indicated for advanced relapsed or refractory multiple myeloma. It acts as an immunological connector to direct the body's T-cells to target and eliminate BCMA-positive cancer cells. It is clinically accessible in Boao Lecheng under Hainan's special-import pilot-zone policy.

Regulatory Approvals

• FDA — approved (2022) — label
• EMA — approved (2022) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• MajesTEC-1 — Moreau et al., N Engl J Med 2022 (NCT04557098) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/tecvayli
• https://www.nmpa.gov.cn/