Teclistamab

Teclistamab, marketed as Tecvayli, is a humanized bispecific monoclonal antibody developed by Genmab and Janssen. It is a bispecific T‑cell engager (BiTE) that binds B‑cell maturation antigen (BCMA) on malignant plasma cells and CD3 on T cells, redirecting cytotoxic T cells to kill BCMA-expressing myeloma cells.

Indication and use: Teclistamab is indicated for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy. It is administered by subcutaneous injection, with a step‑up dosing strategy during the initial cycle to mitigate cytokine release syndrome (CRS), followed by regular maintenance dosing, typically on a weekly schedule. Patients are monitored for cytopenias, infections, and neurologic signs.

Efficacy and safety: In pivotal trials, teclistamab produced meaningful responses in a substantial subset of patients with RRMM, including deep responses for some. However, treatment carries significant risks. The most common adverse events include cytokine release syndrome, infections, neutropenia, anemia, thrombocytopenia, fatigue, diarrhea, and hypogammaglobulinaemia. Serious adverse events can include high‑grade CRS and neurotoxicity. Management follows standard CRS and neurotoxicity guidelines, with dose modifications and supportive care as needed; infection prevention and monitoring are important components of care.

Regulatory status and history: Teclistamab was approved for RRMM in the United States in 2022 for adults with at least two prior therapies and has since received regulatory scrutiny in other regions. It is part of a broader class of BCMA‑targeted immunotherapies, including other bispecific antibodies and CAR‑T products, used in multiple myeloma.

Research: Ongoing studies are evaluating use in earlier lines of therapy, combination regimens, and potential applications in other BCMA‑expressing diseases, along with long‑term safety and sequencing with other myeloma therapies.