Linvoseltamab
Medication
From Wikipedia, the free encyclopedia
Linvoseltamab, sold under the brand name Lynozyfic, is an anti-cancer medication used for the treatment of people with relapsed or refractory multiple myeloma.[2][4] Linvoseltamab is a bispecific monoclonal antibody that targets CD3 and B-cell maturation antigen (BCMA) (TNFRSF17).[2] It is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager and a recombinant human immunoglobulin (Ig)G4 antibody.[1][5]
| |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | CD3 and BCMA |
| Clinical data | |
| Trade names | Lynozyfic |
| Other names | REGN5458, REGN-5458, linvoseltamab-gcpt |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625085 |
| License data | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6455H9955N1721O2039S47 |
| Molar mass | 145800.47 g·mol−1 |
Lynozyfic was authorized for medical use in the European Union in April 2025,[2][3] and approved for medical use in the United States in July 2025.[5]
Medical uses
In the EU, linvoseltamab is indicated as monotherapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.[2]
In the US, linvoseltamab is indicated for the treatment of adults 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.[5]
Adverse effects
The US prescribing information for linvoseltamab includes a boxed warning for life-threatening cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.[1][5]
History
Efficacy was evaluated in LINKER-MM1 (NCT03761108), an open-label, multi-center multi-cohort trial.[5] The trial included participants who had previously received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.[5] The trial excluded participants with prior BCMA-directed bispecific antibody therapy, prior bispecific T-cell engaging therapy, or prior BCMA CAR-T cell therapy.[5] The efficacy population included 80 participants who had received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[5]
Society and culture
Legal status
In February 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Lynozyfic, intended for the treatment of people with relapsed and refractory multiple myeloma who have received at least three prior therapies.[2] The applicant for this medicinal product is Regeneron Ireland DAC.[2] Lynozyfic was authorized for medical use in the European Union in April 2025.[2][3]
In July 2025, linvoseltamab was approved for medical use in the United States.[5][6] The US Food and Drug Administration (FDA) granted the application for linvoseltamab priority review, orphan drug, and fast track designations.[5]
Names
Linvoseltamab is the international nonproprietary name.[7]
