{"id":"moxetumomab-pasudotox","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"B-cell receptor CD22","category":"target"},{"label":"CD22","category":"gene"},{"label":"L01FB02","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Hairy cell leukemia","category":"indication"},{"label":"Astrazeneca Ab","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Immunoconjugates","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"},{"label":"Immunotoxins","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":79.699,"date":"","count":11,"signal":"Haemolytic uraemic syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=80)"},{"llr":71.906,"date":"","count":10,"signal":"Capillary leak syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=72)"}],"commonSideEffects":[{"effect":"Infusion related reactions","drugRate":"","severity":"common","organSystem":""},{"effect":"Edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"","severity":"common","organSystem":""},{"effect":"Anemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Fluid retention","drugRate":"63%","severity":"common","organSystem":""},{"effect":"Edema peripheral","drugRate":"39%","severity":"common","organSystem":""},{"effect":"Face edema","drugRate":"14%","severity":"common","organSystem":""},{"effect":"Abdominal distension","drugRate":"13%","severity":"common","organSystem":""},{"effect":"Blurred vision","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Weight increased","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Dry eye","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Pleural effusion","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Cataracts","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Ocular discomfort and/or pain","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Ocular swelling/periorbital edema","drugRate":"4%","severity":"common","organSystem":""}],"specialPopulations":{"Lactation":"No data are available regarding the presence of moxetumomab pasudotox-tdfk in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for LUMOXITI and any potential adverse effects on the breastfed child from LUMOXITI or from the underlying maternal condition.","Pregnancy":"Based on its mechanism of action and findings in non-pregnant female animals, LUMOXITI is expected to cause maternal and embryo-fetal toxicity when administered to pregnant woman. There are no available data on LUMOXITI use in pregnant women to inform drug-associated risk of major birth defects and miscarriage. Animal reproduction or developmental toxicity studies have not been conducted with LUMOXITI. Advise pregnant women of the potential risk to fetus.","Geriatric use":"In the combined safety database of HCL patients treated with LUMOXITI, 31% (40/129) of patients treated with LUMOXITI were 65 years of age or older and 8% (10/129) were 75 years of age or older. Exploratory analyses across this population suggest higher incidence of adverse reactions leading to drug discontinuation (23% versus 7%) and renal toxicity (40% versus 20%) for patients 65 years of age or older as compared to those younger than 65 years.","Paediatric use":"Safety and effectiveness have not been established in pediatric patients."},"seriousAdverseEvents":[{"effect":"HUS (Hemolytic Uremic Syndrome)","drugRate":"5%","severity":"serious"},{"effect":"Febrile neutropenia","drugRate":"","severity":"serious"},{"effect":"Hypertension","drugRate":"","severity":"serious"},{"effect":"Grade 3 Edema","drugRate":"1.3%","severity":"serious"},{"effect":"Pericardial effusion","drugRate":"1.3%","severity":"serious"},{"effect":"Ascites","drugRate":"1.3%","severity":"serious"},{"effect":"Fluid overload","drugRate":"1.3%","severity":"serious"},{"effect":"Conjunctival hemorrhage","drugRate":"1.3%","severity":"serious"},{"effect":"Conjunctivitis","drugRate":"1.3%","severity":"serious"},{"effect":"Ocular discharge","drugRate":"1.3%","severity":"serious"}]},"trials":[],"aliases":[],"company":"AstraZeneca","patents":[{"type":"Biologic Exclusivity","filed":"September 13, 2018","source":"FDA Purple Book","status":"Active","expires":"September 13, 2025","territory":"US","patentNumber":"BLA 761104"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MOXETUMOMAB PASUDOTOX","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:26:45.154171+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T03:26:43.554623+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T03:27:01.717012+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:26:52.138653+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:26:45.177944+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MOXETUMOMAB PASUDOTOX","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:26:52.958528+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Elongation factor 2 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:26:53.592036+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1743043/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:26:53.484348+00:00"}},"allNames":"lumoxiti","offLabel":[],"synonyms":["moxetumomab pasudotox","lumoxiti","CAT-8015","HA22","moxetumomab pasudotox-tdfk"],"timeline":[{"date":"2018-09-13","type":"positive","source":"DrugCentral","milestone":"FDA approval (Astrazeneca Ab)"},{"date":"2021-02-08","type":"positive","source":"DrugCentral","milestone":"EMA approval (Astrazeneca Ab)"}],"aiSummary":"Lumoxiti, marketed by AstraZeneca, is a targeted therapy for hairy cell leukemia, a niche but significant indication within hematological malignancies. Its key strength lies in its unique mechanism of action, binding to the CD22 protein on B-cells to mark them for destruction, which differentiates it from competitors like inotuzumab ozogamicin. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics or biosimilars.","approvals":[{"date":"2018-09-13","orphan":true,"company":"ASTRAZENECA AB","regulator":"FDA"},{"date":"2021-02-08","orphan":false,"company":"ASTRAZENECA AB","regulator":"EMA"}],"brandName":"Lumoxiti","ecosystem":[{"indication":"Hairy cell leukemia","otherDrugs":[{"name":"cladribine","slug":"cladribine","company":""},{"name":"interferon alfa-2b","slug":"interferon-alfa-2b","company":"Schering"},{"name":"pentostatin","slug":"pentostatin","company":"Hospira Inc"}],"globalPrevalence":null}],"mechanism":{"target":"B-cell receptor CD22","novelty":"Follow-on","targets":[{"gene":"CD22","source":"DrugCentral","target":"B-cell receptor CD22","protein":"B-cell receptor CD22"}],"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Lumoxiti is a recombinant immunotoxin that consists of a monoclonal antibody fragment linked to a toxin. The antibody fragment binds to the CD22 protein on B-cells, while the toxin is responsible for killing the cells."},"commercial":{"launchDate":"2018","revenueYear":2025,"_launchSource":"DrugCentral (FDA 2018-09-13, ASTRAZENECA AB)","annualRevenue":205,"revenueSource":"SEC 8-K Bristol-Myers Squibb (2026-02-05)","revenueCurrency":"USD","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:59.528179","revenueExtractedBy":"revenue-sec"},"purpleBook":{"bla":"761104","source":"FDA Purple Book","approvalDate":"September 13, 2018","licenseStatus":"Voluntarily Revoked","exclusivityExpiry":"September 13, 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