Linvoseltamab

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	Monograph
MedlinePlus	a625085
License data	US DailyMed: Linvoseltamab
Routes of administration	Intravenous
ATC code	L01FX37 (WHO)
Legal status
Legal status	US: ℞-only1 EU: Rx-only23
Identifiers
CAS Number	2408319-25-3
DrugBank	DB17447
UNII	M3CPC50MZS
KEGG	D12222
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.²⁴ 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.¹⁵

Lynozyfic was authorized for medical use in the European Union in April 2025,²³ and approved for medical use in the United States in July 2025.⁵

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

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.¹⁵

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

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 2025.²³

In July 2025, linvoseltamab was approved for medical use in the United States.⁵⁶ The US Food and Drug Administration (FDA) granted the application for linvoseltamab priority review, orphan drug, and fast track designations.⁵

Linvoseltamab is the international nonproprietary name.⁷

Linvoseltamab is sold under the brand name Lynozyfic.³⁵