Lynozyfic FDA Approval History
Last updated by Judith Stewart, BPharm on July 6, 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.
- FDA accelerated approval of Lynozyfic was based on data from the pivotal Phase 1/2 LINKER-MM1 trial which demonstrated that patients (n=80) experienced a:
- 70% objective response rate (ORR), with 45% achieving a complete response (CR) or better, as determined by an independent review committee; and
- 0.95 month median time to first response (range: 0.5 to 6 months).
- Median duration of response (DoR) that was not reached (95% Confidence Interval [CI]: 12 months to not estimable). The estimated DoR was 89% at 9 months (95% CI: 77 to 95 months) and 72% at 12 months (95% CI: 54 to 84 months) among responders who had a median follow-up of 13 months. - Lynozyfic is administered by intravenous infusion according to a step-up dosing schedule (weekly, then every two-weeks at week 14, and then every four-weeks at week 24 depending on response).
- Lynozyfic carries a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS).
- Warnings and precautions associated with Lynozyfic include serious infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.
- Common adverse reactions (≥20%) include musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea.
Common Grade 3 or 4 laboratory abnormalities (≥30%) include decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.
Development timeline for Lynozyfic
Further information
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