Linvoseltamab FDA Approval Status
FDA Approved: No
Generic name: linvoseltamab
Company: Regeneron Pharmaceuticals, Inc.
Linvoseltamab is a BCMAxCD3 bispecific antibody in development for the treatment of relapsed/refractory (R/R) 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.
- The target action date for the FDA decision is August 22, 2024.
Development timeline for linvoseltamab
Further information
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