The FDA granted accelerated approval to teclistamab-cqyv for treatment of certain patients of myeloma.
The indication applies to use of teclistamab-cqyv (Tecvayli, Janssen Biotech) for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Teclistamab-cqy is a bispecific B-cell maturation antigen-directed CD3 T-cell engager.
The FDA based the approval on results of the single-arm, multi-cohort, open-label, multicenter MajesTEC-1 study.
The efficacy
