Teclistamab: First Approval

Teclistamab (TECVAYLI®), a bispecific antibody that targets CD3 and B cell maturation antigen (BCMA), is being developed by Janssen Research and Development for the treatment of relapsed or refractory multiple myeloma. Teclistamab was recently granted conditional approval in the EU for the treatment of adult patients with relapsed and refractory multiple myeloma who have received three or more prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and have demonstrated disease progression on the last therapy. Teclistamab was subsequently approved in the US for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody). This article summarizes the milestones in the development of teclistamab leading to this first approval for relapsed or refractory multiple myeloma.