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.[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 usesIn 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 effectsThe 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] HistoryEfficacy 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 cultureLegal statusIn 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] NamesLinvoseltamab is the international nonproprietary name.[7] Linvoseltamab is sold under the brand name Lynozyfic.[3][5] References
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