Linvoseltamab FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 21, 2024.
FDA Approved: No
Generic name: linvoseltamab
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Linvoseltamab is a BCMAxCD3 bispecific antibody in development for the treatment of relapsed/refractory multiple myeloma.
- Multiple myeloma is a blood cancer characterized by the proliferation of cancerous plasma cells (multiple myeloma cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury.
- Linvoseltamab an investigational treatment designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
- On February 21, 2024, Regeneron announced that the U.S. Food and Drug Administration (FDA) had accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.
- On August 20, 2024, Regeneron announced that the FDA had issued a Complete Response Letter (CRL) for the BLA for linvoseltamab in R/R MM. The sole approvability issue identified was related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company’s product candidate.
Development timeline for linvoseltamab
Further information
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