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Review
. 2022 Nov;82(16):1613-1619.
doi: 10.1007/s40265-022-01793-1.

Teclistamab: First Approval

Connie Kang  1
Affiliations
Review

Teclistamab: First Approval

Connie Kang. Drugs. 2022 Nov.

Abstract

Teclistamab (TECVAYLI®), a bispecific antibody that targets CD3 and B cell maturation antigen (BCMA), is being developed by Janssen Research and Development for the treatment of relapsed or refractory multiple myeloma. Teclistamab was recently granted conditional approval in the EU for the treatment of adult patients with relapsed and refractory multiple myeloma who have received three or more prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and have demonstrated disease progression on the last therapy. Teclistamab was subsequently approved in the US for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody). This article summarizes the milestones in the development of teclistamab leading to this first approval for relapsed or refractory multiple myeloma.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Connie Kang is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

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Key milestones in the development of teclistamab for the treatment of relapsed or refractory multiple myeloma. Est. estimated, MM multiple myeloma, PRIME Priority Medicines, R/R relapsed or refractory
See this image and copyright information in PMC

References

    1. Usmani SZ, Garfall AL, van de Donk N, et al. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021;398(10301):665–674. doi: 10.1016/S0140-6736(21)01338-6. - DOI - PubMed
    1. Johnson & Johnson. Janssen marks first approval worldwide for TECVAYLI® (teclistamab) with EC authorisation of first-in-class bispecific antibody for the treatment of patients with multiple myeloma [media release]. 24 Aug 2022. https://www.jnj.com.
    1. Janssen Biologics B.V. TECVAYLI: EU summary of product characteristics. 2022. https://ec.europa.eu. Accessed 29 Sep 2022.
    1. U.S. Food & Drugs Administration. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma [media release]. 26 Oct 2022. https://www.fda.gov
    1. Johnson & Johnson. Pharmaceutical pipeline. 2022. https://www.investor.jnj.com. Accessed 29 Sep 2022.

MeSH terms