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.
- 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.
- Assistance programmes
- Libtayo Surround
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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.
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- 2 Jul 2025ApprovalUS
Accelerated approval (LINKER-MM1) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Relapsed/refractory myeloma after ≥4 lines (accelerated) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
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