FDA Approval Summary: Teclistamab–A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma
Andrea Baines, Bindu Kanapuru, Jay Zhao, Lauren Price, Nan Zheng, Robyn Konicki, Michael L. Manning, Brenda J. Gehrke, Marc R. Theoret, Nicole Gormley
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.