Linvoseltamab
| 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 | Lynozyfic |
| 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 |
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]
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
[edit]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
[edit]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
[edit]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
[edit]Legal status
[edit]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
[edit]Linvoseltamab is the international nonproprietary name.[7]
Linvoseltamab is sold under the brand name Lynozyfic.[3][5]
References
[edit]- ^ a b c https://www.regeneron.com/downloads/lynozyfic_fpi.pdf [bare URL PDF]
- ^ a b c d e f g h "Lynozyfic EPAR". European Medicines Agency (EMA). 27 February 2025. Retrieved 6 March 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c d "Lynozyfic Product information". Union Register of medicinal products. 25 April 2025. Retrieved 3 May 2025.
- ^ Avigan ZM, Rattu MA, Richter J (February 2025). "An evaluation of linvoseltamab for treatment of relapsed/refractory multiple myeloma". Expert Opinion on Biological Therapy. 25 (3): 221–228. doi:10.1080/14712598.2025.2465825. PMID 39923122.
- ^ a b c d e f g h i j k "FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 2 July 2025. Retrieved 4 July 2025.
This article incorporates text from this source, which is in the public domain.
- ^ "Lynozyfic (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma" (Press release). Regeneron Pharmaceuticals. 2 July 2025. Retrieved 4 July 2025 – via GlobeNewswire.
- ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.
External links
[edit]- "Linvoseltamab (Code C158504)". NCI Thesaurus. Archived from the original on 27 October 2020.
- Clinical trial number NCT03761108 for "Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma (LINKER-MM1)" at ClinicalTrials.gov
