Elranatamab: First Approval

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest 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. Sohita Dhillon is a contracted 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.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Elranatamab (elranatamab-bcmm; ELREXFIO™) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T cell engager being developed by Pfizer for the treatment of multiple myeloma (MM). Elranatamab bridges CD3 on T cells with BCMA expressed on multiple myeloma cells, thereby activating T cells to induce T cell-mediated cytotoxicity against myeloma cells. In August 2023, elranatamab received its first approval in the USA for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Elranatamab received accelerated approval for this indication based on response rate and durability of response, and continued approval may be contingent on the demonstration of clinical benefit in a confirmatory trial(s). Elranatamab is under regulatory review for RRMM in the EU, Japan and several other countries worldwide. Clinical studies of elranatamab are also underway in countries around the world. This article summarizes the milestones in the development of elranatamab leading to this first approval for the treatment of RRMM.  

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