Lynozyfic FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 11, 2025.
FDA Approved: Yes (First approved July 2, 2025)
Brand name: Lynozyfic
Generic name: linvoseltamab-gcpt
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed or refractory multiple myeloma.
- Lynozyfic is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
- This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- 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.
- Lynozyfic is a 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.
Development timeline for Lynozyfic
| Date | Article |
|---|
| Jul 2, 2025 | Approval FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple Myeloma |
| Feb 11, 2025 | Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma |
| Aug 20, 2024 | Regeneron Provides Update on Biologics License Application for Linvoseltamab |
| Jun 16, 2024 | Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma |
| Apr 7, 2024 | Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma |
| Feb 21, 2024 | Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review |
| Dec 7, 2023 | Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma |
| May 25, 2023 | Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma |
| Dec 12, 2022 | Linvoseltamab (BCMAxCD3) Initial Pivotal Phase 2 Data Show Clinically Meaningful Responses in Patients with Heavily Pre-treated Multiple Myeloma |
| Dec 11, 2021 | New REGN5458 (BCMAxCD3) Phase 1 Data Show 75% Response Rate at Highest Dose Levels Studied in Patients with Heavily Pretreated Multiple Myeloma |
| Dec 5, 2020 | Regeneron's BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1 |
| Dec 8, 2019 | First Clinical Data for REGN5458 (BCMAxCD3) Show Positive Preliminary Results in Multiple Myeloma |
Further information
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