Drug intelligence / Profile preview

linvoseltamab

Development stage
Approved
Lead developer
Regeneron Pharmaceuticals
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Linvoseltamab is a **fully human BCMAxCD3 bispecific monoclonal antibody** developed by Regeneron for plasma cell disorders, most notably relapsed or refractory multiple myeloma. It is designed to bind **B-cell maturation antigen** on malignant plasma cells and **CD3** on T cells, thereby redirecting T-cell cytotoxicity toward BCMA-expressing myeloma cells. The program was previously known as **REGN5458** and advanced through the Phase 1/2 **LINKER-MM1** study, which supported regulatory filings in heavily pretreated multiple myeloma. Linvoseltamab has also been studied in combinations and in earlier disease settings, including smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, AL amyloidosis, and exploratory non-oncology use in severe IgE-mediated food allergy. In the United States it is marketed as **Lynozyfic**, with the approved product using the nonproprietary name **linvoseltamab-gcpt**.

Brand names
Lynozyfic
Other names
linvoseltamab-gcpt
02

Targets

CD3 (T-cell surface glycoprotein CD3)BCMA (B-cell maturation antigen)

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