LYNOZYFIC (linvoseltamab-gcpt)
LYNOZYFIC is indicated for the treatment of Multiple Myeloma.
How LYNOZYFIC Works
Linvoseltamab-gcpt functions as a bispecific T-cell engaging antibody that simultaneously binds to two different targets. It attaches to the CD3 receptor on the surface of T-cells and the B-cell maturation antigen (BCMA) found on multiple myeloma cells. This dual binding activates the T-cells and triggers the release of proinflammatory cytokines. This immune response results in the lysis, or destruction, of the targeted multiple myeloma cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-07-02
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
LYNOZYFIC Approval History
What LYNOZYFIC Treats
1 indicationsLYNOZYFIC is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
LYNOZYFIC Boxed Warning
CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY, INCLUDING IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.4 , 2.5) and Warnings ...
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY, INCLUDING IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.4 , 2.5) and Warnings and Precautions (5.1) ]. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS during treatment. Manage neurologic toxicity, including ICANS, withhold LYNOZYFIC until neurologic toxicity, including ICANS resolves, and modify the next dose or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.4 , 2.5) and Warnings and Precautions (5.2) ]. Because of the risk of CRS and neurologic toxicity, including ICANS, LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LYNOZYFIC REMS [see Warnings and Precautions (5.3) ]. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves and modify the next dose or permanently discontinue based on severity. ( 2.2 , 2.4 , 2.5 , 5.1 ) Neurologic Toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threate
LYNOZYFIC Target & Pathway
ProTarget
A protein highly expressed on malignant plasma cells in multiple myeloma. BCMA-targeted therapies, including CAR-T cells and bispecific antibodies, can eliminate myeloma cells while sparing most normal immune cells.
LYNOZYFIC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LYNOZYFIC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LYNOZYFIC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LYNOZYFIC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05828511 LINKER-MM4 | R5458-ONC-2158 2022-500800-24-00 | Ph 1, Ph 2 | recruiting | A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment |
| NCT07222761 LINKER-MM5 | R5458-ONC-2246 2024-519504-27-00 | Ph 3 | recruiting | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT06369467 | R5458-668-ALG-2219 2024-511032-27-00 | Ph 1 | recruiting | Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy |
| NCT07009899 RECLAIM | PRO00056695 | Ph 2 | not yet recruiting | BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) |
| NCT06292780 LINKER-AL2 | R5458-ONC-2274 2023-507809-34-00 | Ph 1, Ph 2 | recruiting | A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) |
| NCT03761108 LINKER-MM1 | R5458-ONC-1826 2024-511454-45-00 | Ph 1, Ph 2 | recruiting | Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma |
| NCT07455851 | R17372-HM-2493 2025-522776-93-00 | Ph 1, Ph 2 | recruiting | A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT06669247 COSTIMM | R7945-ONC-22110 2024-513126-39-00 | Ph 1, Ph 2 | recruiting | A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT05955508 | R5458-ONC-2256 2023-503524-11-00 | Ph 2 | active not recruiting | A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma |
| NCT06140524 LINKER-MGUS1 | R5458-ONC-2257 2023-505242-25-00 | Ph 2 | recruiting | A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma |
| NCT07181941 | RG1125714 NCI-2025-06211, FHIRB0020980 | Ph 1, Ph 2 | recruiting | Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma |
| NCT06932562 | EMN39 2024-519827-16-00 | Ph 3 | recruiting | A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant |
| NCT07393282 LINKER-SMM2 | R5458-HM-24145 2025-523252-31-00 | Ph 3 | not yet recruiting | A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) |
| NCT05730036 LINKER-MM3 | R5458-ONC-2245 2022-501396-62-00 | Ph 3 | recruiting | A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT07428369 LINKER-MM8 | R5458-HM-2504 2025-524032-19-00 | Ph 2, Ph 3 | not yet recruiting | A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) |
| NCT05137054 | R5458-ONC-2012 2020-004638-39, 2023-506247-42-00 | Ph 1 | recruiting | A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments |
| NCT06910124 | 20241138 | Ph 2 | recruiting | Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse |
| NCT06376526 IMMUNOPLANT | 20230236 | Ph 2 | recruiting | IMMUNOPLANT for Newly Diagnosed Multiple Myeloma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYNOZYFIC FDA Label Details
Indications & Usage
FDA Label (PDF)LYNOZYFIC is indicated for the treatment of Multiple Myeloma.
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY, INCLUDING IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment