Teclistamab-cqyv granted accelerated approval by the FDA

On October 25, 2022, it was announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to teclistamab‑cqyv for the treatment of adult patients with relapsed/ refractory multiple myeloma (RMMM) who have previously been treated with ≥4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.¹

Teclistamab‑cqyv is a humanized, bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager that received conditional marketing authorization for the treatment of RRMM from the European Medicines Agency (EMA) in August, 2022.

The FDA approval is based on positive results from the phase I/II MajesTEC-1 trial of teclistamab‑cqyv in patients with RRMM who had received ≥3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, but who had not received prior BCMA-targeted therapy (NCT03145181; NCT04557098).¹

The main outcome from MajesTEC-1 was an overall response rate of 61.8% (95% confidence interval, 52.1─70.9), from a median follow-up period of 7.4 months.¹

Due to a prevalence of cytokine release syndrome of 72% and neurologic toxicity of 57%, teclistamab-cqyv will carry a boxed warning for life-threatening neurological events in the US and will only be available to patients through a drug-specific FDA-approved Risk Evaluation and Mitigation Strategy (REMS).¹