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]
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]
12345678"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.
↑World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.
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
