FDA Approval Summary: Teclistamab – A Bispecific CD3 T-cell Engager for Patients with Relapsed or Refractory Multiple Myeloma

Abstract On October 25, 2022, the FDA granted accelerated approval to teclistamab-cqyv (TECVAYLI; Janssen Biotech) 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 mAb. Substantial evidence of effectiveness was obtained from the MajesTEC-1 trial, a phase I/II, single-arm, open-label, multicenter study. Patients received step-up doses of teclistamab at 0.06 and 0.3 mg/kg followed by 1.5 mg/kg subcutaneously once weekly until disease progression or unacceptable toxicity. An overall response rate of 61.8% was observed, with a complete response or better rate of 28.2%. Cytokine release syndrome occurred in 72% of patients, and neurologic toxicity occurred in 57%, including immune effector cell–associated neurotoxicity syndrome in 6%. Due to the risk of cytokine release syndrome and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome, the US Prescribing Information for teclistamab includes a boxed warning, and teclistamab is available only through a restricted program under a risk evaluation and mitigation strategy. Here, we summarize the data and FDA review supporting the accelerated approval of teclistamab, a B-cell maturation antigen–directed bispecific antibody that was the first bispecific CD3 T-cell engager approved for treatment of multiple myeloma.