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Shaji K. Kumar, MD

Prashant Kapoor, MD, FACP


FDA Brief: Teclistamab-cqyv Granted Accelerated Approval in Resistant Myeloma

By: JNCCN 360 Staff
Posted: Wednesday, October 26, 2022

On October 25, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv (Tecvayli) for the treatment of adults with relapsed or refractory multiple myeloma who received at least four previous lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Teclistamab is a first-in-class bispecific T-cell engager antibody administered subcutaneously and is supplied as 30-mg/3-mL and 153-mg/1.7-mL single-dose vials.

The regulatory decision is supported by data from the phase II MajesTEC-1 trial, which were published over the summer in The New England Journal of Medicine. The investigators reported that teclistimab yielded an objective response rate of 61.8% (95% confidence interval [CI] = 52.1%–70.9%) by independent review committee assessment and using the 2016 criteria from the International Myeloma Working Group. At median follow-up of 7.4 months in responders, the estimated duration of response rate at 6 months with teclistamab was 90.6% (95% CI = 80.3%–95.7%); at 9 months, the rate was 66.5% (95% CI = 38.8%–83.9%).

The safety information for teclistamab includes a boxed warning for cytokine-release syndrome and neurologic toxicity including immune effector cell–associated neurotoxicity syndrome. It also includes warnings and precautions for hepatotoxicity, infections, neutropenia, hypersensitivity, and other administrative reactions and embryofetal toxicity. Teclistamab is available only through a restricted Risk Evaluation and Mitigation Strategy program.

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