All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.

The Multiple Myeloma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
  TRANSLATE

The Multiple Myeloma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Multiple Myeloma Hub cannot guarantee the accuracy of translated content. The Multiple Myeloma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact

Teclistamab-cqyv granted accelerated approval by the FDA

Oct 27, 2022
Share:
Learning objective: After reading this article, learners will be able to cite a new development in the treatment of MM.

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 

  1. U.S. Food and Drug Administration (FDA). FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma. Published Oct 25, 2022. Accessed Oct 27, 2022.