{"entity":{"id":"belantamab-mafodotin","kind":"drug","name":"Belantamab mafodotin","aka":[],"tldr":"A myeloma ADC that was withdrawn in 2022 then came back in 2025 after strong trials in earlier lines.","summary":"Belantamab mafodotin is an afucosylated anti-BCMA IgG1 antibody linked through a non-cleavable linker to MMAF, a non-permeable tubulin inhibitor; it kills through the payload and through enhanced antibody-dependent cellular cytotoxicity. It received accelerated approval in 2020 for myeloma after four or more lines (DREAMM-2), was withdrawn in 2022 when DREAMM-3 failed to confirm benefit, and returned in 2025 in the US and EU for relapsed or refractory myeloma after at least one prior line, after DREAMM-7 (with bortezomib and dexamethasone) and DREAMM-8 (with pomalidomide and dexamethasone) showed progression-free and overall survival benefits. Dosing is 2.5 mg/kg every 3 weeks in DREAMM-7 or 2.5 then 1.9 mg/kg every 4 weeks in DREAMM-8. Keratopathy occurs in most patients and carries a boxed warning, so an ophthalmology-based REMS is required.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Belantamab_mafodotin","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Belantamab%20mafodotin"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["adc"],"targets":["bcma"],"drugs":[],"companies":["gsk"],"institutions":[],"pathways":[],"terms":["mc-non-cleavable"],"trials":["nct06868654","nct06956170","nct04162210","nct06679101","nct06868667","nct07084896","nct07150091","nct07227311","nct07217184","nct05714839","nct07150104"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Blenrep","modality":"ADC","payload":"MMAF (tubulin inhibitor, non-permeable)","linker":"mc, non-cleavable","mechanism":"Afucosylated anti-BCMA IgG1 with MMAF; ADCC plus payload.","approvals":[{"region":"US","year":2020,"indication":"Relapsed myeloma ≥4 lines (accelerated; withdrawn 2022)"},{"region":"US","year":2025,"indication":"Relapsed/refractory myeloma after ≥1 prior line, in combination"},{"region":"EU","year":2025,"indication":"R/R myeloma with BorDex or PomDex; 23 Jul 2025"}],"mechanismSteps":["Antibody binds BCMA on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","MMAF (non-permeable) is released inside the cell","Microtubule assembly is blocked; mitosis arrests","Tumour cell dies by apoptosis"],"dosing":{"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)","modifications":"Hold and reduce for keratopathy or visual acuity decline per REMS","monitoring":"Ophthalmic exam before each dose; preservative-free lubricants","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Keratopathy","note":"Ocular events in most patients; boxed warning"},{"event":"Thrombocytopenia"},{"event":"Blurred vision"},{"event":"Dry eye"},{"event":"Infections"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended in combination regimens for relapsed myeloma (2025)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2020-08-05","type":"accelerated-approval","region":"US","note":"Accelerated approval, relapsed/refractory myeloma after ≥4 lines (DREAMM-2)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent"},{"date":"2022-11-22","type":"withdrawal","region":"US","note":"Withdrawn after DREAMM-3 failed to confirm benefit","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-02-06","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 2.5 years after its accelerated approval.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma","indication":"Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent"},{"date":"2025-07-23","type":"crl","region":"US","note":"Complete response letter on combination filing; resubmitted","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-10","type":"approval","region":"US","note":"Approval in combination regimens for relapsed/refractory myeloma after ≥1 line (DREAMM-7/8)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/belantamab-mafodotin/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"}],"company":[{"id":"gsk","kind":"company","name":"GSK","route":"/companies/gsk/"}],"term":[{"id":"approval-withdrawal","kind":"term","name":"Indication withdrawal","route":"/terms/approval-withdrawal/"},{"id":"mc-non-cleavable","kind":"term","name":"Maleimidocaproyl (mc), non-cleavable","route":"/terms/mc-non-cleavable/"},{"id":"mmaf","kind":"term","name":"MMAF","route":"/terms/mmaf/"},{"id":"ocular-toxicity","kind":"term","name":"Ocular toxicity (keratopathy, blurred vision)","route":"/terms/ocular-toxicity/"},{"id":"tubulin-inhibitor-payloads","kind":"term","name":"Tubulin inhibitor payloads","route":"/terms/tubulin-inhibitor-payloads/"}],"trial":[{"id":"nct06679101","kind":"trial","name":"A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethas","route":"/trials/nct06679101/"},{"id":"nct07227311","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Mult","route":"/trials/nct07227311/"},{"id":"nct05714839","kind":"trial","name":"A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatme","route":"/trials/nct05714839/"},{"id":"nct06956170","kind":"trial","name":"All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myelo","route":"/trials/nct06956170/"},{"id":"nct06868654","kind":"trial","name":"China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexame","route":"/trials/nct06868654/"},{"id":"dreamm-7","kind":"trial","name":"DREAMM-7","route":"/trials/dreamm-7/"},{"id":"dreamm-8","kind":"trial","name":"DREAMM-8","route":"/trials/dreamm-8/"},{"id":"nct06868667","kind":"trial","name":"Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dex","route":"/trials/nct06868667/"},{"id":"nct04126200","kind":"trial","name":"Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple","route":"/trials/nct04126200/"},{"id":"nct04162210","kind":"trial","name":"Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple","route":"/trials/nct04162210/"},{"id":"nct07150104","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants Wi","route":"/trials/nct07150104/"},{"id":"nct07217119","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM","route":"/trials/nct07217119/"},{"id":"nct07217184","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM","route":"/trials/nct07217184/"},{"id":"nct07084896","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM","route":"/trials/nct07084896/"},{"id":"nct07150091","kind":"trial","name":"Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM","route":"/trials/nct07150091/"}],"person":[{"id":"sagar-lonial","kind":"person","name":"Sagar Lonial","route":"/people/sagar-lonial/"}],"biomarker":[{"id":"bcma-expression","kind":"biomarker","name":"BCMA expression","route":"/biomarkers/bcma-expression/"}]}}