Chemistry:Linvoseltamab
Linvoseltamab, sold under the brand name Lynozyfic, is an anti-cancer medication used for the treatment of people with relapsed or refractory multiple myeloma.[1][2] Linvoseltamab is a bispecific monoclonal antibody that targets CD3 and B-cell maturation antigen (BCMA) (TNFRSF17).[1] It is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager and a recombinant human immunoglobulin (Ig)G4 antibody.[3][4]
Lynozyfic was authorized for medical use in the European Union in April 2025,[1][5] and approved for medical use in the United States in July 2025.[4]
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.[1]
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.[4]
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.[3][4]
History
Efficacy was evaluated in LINKER-MM1 (NCT03761108), an open-label, multi-center multi-cohort trial.[4] 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.[4] The trial excluded participants with prior BCMA-directed bispecific antibody therapy, prior bispecific T-cell engaging therapy, or prior BCMA CAR-T cell therapy.[4] 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.[4]
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.[1] The applicant for this medicinal product is Regeneron Ireland DAC.[1] Lynozyfic was authorized for medical use in the European Union in April 2025.[1][5]
In July 2025, linvoseltamab was approved for medical use in the United States.[4][6] The US Food and Drug Administration (FDA) granted the application for linvoseltamab priority review, orphan drug, and fast track designations.[4]
Names
Linvoseltamab is the international nonproprietary name.[7]
Linvoseltamab is sold under the brand name Lynozyfic.[5][4]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Lynozyfic EPAR". 27 February 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/lynozyfic. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "An evaluation of linvoseltamab for treatment of relapsed/refractory multiple myeloma". Expert Opinion on Biological Therapy 25 (3): 221–228. February 2025. doi:10.1080/14712598.2025.2465825. PMID 39923122.
- ↑ 3.0 3.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedLynozyfic FDA label - ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 "FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma". 2 July 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma.
This article incorporates text from this source, which is in the public domain.
- ↑ 5.0 5.1 5.2 "Lynozyfic Product information". 25 April 2025. https://ec.europa.eu/health/documents/community-register/html/h1917.htm.
- ↑ "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.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information 36 (3). 2022.
External links
- "Linvoseltamab (Code C158504)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C158504.
- 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
 |  |
