Overview
Linvoseltamab is an investigational bispecific antibody. It promotes the interaction of B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Linvoseltamab (Lynozyfic™): A Comprehensive Clinical and Pharmacological Monograph on a Novel BCMAxCD3 Bispecific T-Cell Engager for Relapsed/Refractory Multiple Myeloma
I. Executive Summary & Introduction to the Multiple Myeloma Therapeutic Landscape
A. The Unmet Need in Heavily Pre-treated Multiple Myeloma
Multiple myeloma (MM) is a hematologic malignancy of plasma cells that remains incurable despite significant therapeutic advances over the past two decades.[1] The clinical course of the disease is characterized by a pattern of response to therapy followed by inevitable relapse, with each subsequent remission becoming progressively shorter.[1] This sequential treatment approach has led to the emergence of a heavily pre-treated patient population with disease that is refractory to multiple classes of standard-of-care agents. The therapeutic backbone for MM has historically relied on three main drug classes: proteasome inhibitors (PIs) such as bortezomib and carfilzomib; immunomodulatory drugs (IMiDs) like lenalidomide and pomalidomide; and, more recently, anti-CD38 monoclonal antibodies (MAbs) such as daratumumab and isatuximab.[2] Patients whose disease progresses despite treatment with agents from each of these three classes are defined as having "triple-class refractory" multiple myeloma, a clinical state associated with a particularly poor prognosis and exceedingly limited effective therapeutic options.[1] This growing population of patients with advanced, multi-drug resistant disease represents a critical unmet medical need, demanding the development of novel therapeutic strategies with distinct mechanisms of action.
B. The Emergence of B-Cell Maturation Antigen (BCMA) as a Transformative Target
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/19 | Not Applicable | Not yet recruiting | |||
2025/06/08 | Phase 2 | Not yet recruiting | |||
2025/04/17 | Phase 3 | Not yet recruiting | European Myeloma Network B.V. | ||
2025/04/04 | Phase 2 | Recruiting | Dickran Kazandjian, MD | ||
2024/11/01 | Phase 1 | Recruiting | |||
2024/04/19 | Phase 2 | Recruiting | Dickran Kazandjian, MD | ||
2024/04/17 | Phase 1 | Recruiting | |||
2024/03/05 | Phase 1 | Recruiting | |||
2023/11/20 | Phase 2 | Recruiting | |||
2023/07/21 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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