[FDA Approval] BCMA/CD3 Bispecific Antibody Approved on July 2, 2025
On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab (brand name: Lynozyfic) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM). Lynozyfic is a BCMA/CD3 bispecific T-cell engager antibody, approved under a REMS program due to the risk of serious immune-related side effects.
About the Disease: Multiple Myeloma
Multiple myeloma is a cancer of plasma cells that can cause anemia, bone lesions, kidney dysfunction, and hypercalcemia. New treatments are especially needed in relapsed or refractory cases after standard therapies have failed.
Drug Summary
- Generic name: linvoseltamab
- Brand name: Lynozyfic
- Company: Regeneron Pharmaceuticals
- Approval date: July 2, 2025
- Indication: Relapsed or refractory multiple myeloma (RRMM)
- Mechanism: Bispecific antibody targeting BCMA on myeloma cells and CD3 on T cells
- Clinical trial: LINKER-MM1 (Phase 1/2)
- Key AEs: CRS (cytokine release syndrome), ICANS (neurotoxicity)
For Patients
Lynozyfic recruits your own immune T cells to attack myeloma cells without needing cell collection like CAR-T therapy. It’s designed to be administered more quickly and broadly.
Significance
This approval provides a new treatment option for RRMM patients, especially those who have failed prior BCMA-targeted therapies, and may impact future treatment strategies.
References
Source: Drugs@FDA
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