Linvoseltamab

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Linvoseltamab
Linvoseltamab.png
Monoclonal antibody
Type Whole antibody
Source Human
Target CD3 and BCMA
Clinical data
Trade names Lynozyfic
Other namesREGN5458, REGN-5458, linvoseltamab-gcpt
AHFS/Drugs.com Lynozyfic
License data
Routes of
administration 		Intravenous
ATC code
  • None
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]

Contents

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

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]

Linvoseltamab is sold under the brand name Lynozyfic. [3] [5]

References

  1. 1 2 3 "Highlights of prescribing information - LYNOZYFIC™ (linvoseltamab-gcpt) injection, for intravenous use" (PDF). Archived from the original (PDF) on 3 July 2025.
  2. 1 2 3 4 5 6 7 8 "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.
  3. 1 2 3 4 "Lynozyfic Product information". Union Register of medicinal products. 25 April 2025. Retrieved 3 May 2025.
  4. ↑ 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.
  5. 1 2 3 4 5 6 7 8 9 10 11 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. ↑ "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.
  7. ↑ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl: 10665/363551 .
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