Belantamab mafodotin
A myeloma ADC that was withdrawn in 2022 then came back in 2025 after strong trials in earlier lines.
DREAMM-7 (with bortezomib/dexamethasone) and DREAMM-8 (with pomalidomide/dexamethasone) showed PFS and OS benefits; re-approved in 2025 in the US and EU in second-line myeloma. Ocular toxicity (keratopathy) requires an ophthalmology-based REMS.
1.Antibody binds BCMA on the tumour cell surface
- Route
- IV infusion
- Schedule
- 2.5 mg/kg every 3 weeks with bortezomib/dexamethasone (DREAMM-7) or 2.5 mg/kg then 1.9 mg/kg every 4 weeks with pomalidomide/dexamethasone (DREAMM-8)
- Dose modifications
- Hold and reduce for keratopathy or visual acuity decline per REMS
- Monitoring
- Ophthalmic exam before each dose; preservative-free lubricants
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- 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. Withdrawn from the US market in 2022–2023 and re-approved in 2025 in combination; ocular monitoring under a REMS.
- 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. Plans require documented prior lines and enrolment in the ocular REMS.
- Assistance programmes
- Together with GSK Oncology
- 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.
- Appraised for
- With bortezomib and dexamethasone for relapsed or refractory multiple myeloma after 1 or more treatments (DREAMM-7)
- Notes
- The UK was the first country to re-license belantamab (MHRA, April 2025) and NICE recommended it in 2025. TA number not verified; follow the NICE search link.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: belantamab mafodotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 5 Aug 2020ApprovalUS
Accelerated approval, relapsed/refractory myeloma after ≥4 lines (DREAMM-2) source
- 22 Nov 2022WithdrawalUS
Withdrawn after DREAMM-3 failed to confirm benefit source
- 23 Jul 2025Complete response letterUS
Complete response letter on combination filing; resubmitted source
- Oct 2025ApprovalUS
Approval in combination regimens for relapsed/refractory myeloma after ≥1 line (DREAMM-7/8) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Relapsed myeloma ≥4 lines (accelerated; withdrawn 2022) |
| US | 2025 | Relapsed/refractory myeloma after ≥1 prior line, in combination |
| Adverse event |
|---|
| Keratopathy |
| Thrombocytopenia |
| Blurred vision |
| Dry eye |
| Infections |
Ocular events in most patients; boxed warning. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | — |
| United Kingdom | NICE: recommended in combination regimens for relapsed myeloma (2025) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Belantamab mafodotin" OR ABSTRACT:"Belantamab mafodotin" OR TITLE:"Blenrep" OR ABSTRACT:"Blenrep") 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 Belantamab mafodotin, not a curated reading list.
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