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Linvoseltamab is Regeneron's BCMA bispecific, approved in July 2025 with the highest complete-response rate of the class in its pivotal study.
Linvoseltamab is a fully human IgG4 BCMAxCD3 bispecific antibody built on Regeneron's Veloci-Bi platform, given intravenously with step-up dosing and moved to every-4-week dosing in patients who respond. In LINKER-MM1, patients with at least 3 prior lines including an anti-CD38 antibody had ORR 70% and CR or better 45%, the highest complete response rate of the BCMA bispecific class in a pivotal study. The FDA granted accelerated approval on 2 July 2025 after at least 4 prior lines, and the EU approved it in 2025. LINKER-MM3, comparing it with elotuzumab-pomalidomide-dexamethasone, is the confirmatory phase 3. Its place alongside teclistamab and elranatamab, which reached the market earlier, depends on whether the deeper responses and less frequent dosing hold up. It is the third BCMA bispecific for myeloma, notable for how many patients reach complete remission.
Backbone ribbon from PDB 12ES. RCSB PDB 12ES. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Fully human IgG4 BCMA×CD3 bispecific (Veloci-Bi), IV with step-up. Connects to BCMA and CD3.
1.One arm of Linvoseltamab binds BCMA on the cancer cell.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting. FDA-approved 2025.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: linvoseltamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adult patients 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.
Accelerated approval (LINKER-MM1) The confirmatory requirement was still open 1.2 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Relapsed/refractory myeloma after ≥4 lines (accelerated) |
| EU | 2025 | R/R myeloma ≥3 lines; 23 Apr 2025 (conditional) · Conditional marketing authorisation |
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Query for this drug: (TITLE:"Linvoseltamab" OR ABSTRACT:"Linvoseltamab" OR TITLE:"Lynozyfic" OR ABSTRACT:"Lynozyfic") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Linvoseltamab, not a curated reading list.
Shares LINKER-MM1, Caution: T-cell redirectors and infections, BCMA, CD3.
Shares Caution: T-cell redirectors and infections, BCMA expression, BCMA, CD3.
Shares Caution: T-cell redirectors and infections, BCMA, CD3, Relapsed or refractory multiple myeloma.
Shares Caution: T-cell redirectors and infections, BCMA expression, BCMA, CD3.
Shares BCMA expression, BCMA, Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares BCMA expression, Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares BCMA, Relapsed or refractory multiple myeloma, Multiple myeloma.
Shares BCMA, Pivotal (registrational) trial, Multiple myeloma.