OnCo
drugsProductApproved2025🇪🇺🇬🇧

Linvoseltamab

Linvoseltamab is Regeneron's BCMA bispecific, approved in July 2025 with the highest complete-response rate of the class in its pivotal study.

LINKER-MM1: ORR 70%, CR or better 45% in ≥3 prior lines including anti-CD38. Accelerated approval 2 July 2025 (≥4 prior lines); EU approval 2025. Response-adapted dosing to every 4 weeks. LINKER-MM3 (vs elotuzumab-Pd) confirmatory.

Schematic of the modality · Bispecific T-cell engager (BCMA×CD3) · not a molecule; see the T-cell engagers (bispecific) page
How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
Modality
Bispecific T-cell engager (BCMA×CD3)
Mechanism
Fully human IgG4 BCMA×CD3 bispecific (Veloci-Bi), IV with step-up.
Brand / code
Lynozyfic
Medicare
Part B (clinician-administered)

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.

Commercial insurance
covered with prior authorisation

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.

Not yet researchedSearch NICE
Notes
MHRA-licensed 2025; NICE appraisal in progress.

Sources: NICE search: linvoseltamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 2 Jul 2025ApprovalUS

    Accelerated approval (LINKER-MM1) source

Approvals

RegionYearIndication
US2025Relapsed/refractory myeloma after ≥4 lines (accelerated)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
18 studies14 recruiting13 Phase 26 Phase 3
Search “Linvoseltamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Linvoseltamab
intervention: Linvoseltamab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend31 papers in the last 12 months+288% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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