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Lumoxiti (MOXETUMOMAB PASUDOTOX)
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.
At a glance
| Generic name | MOXETUMOMAB PASUDOTOX |
|---|---|
| Sponsor | AstraZeneca |
| Target | B-cell receptor CD22 |
| Modality | Antibody drug conjugate |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2018 |
| Annual revenue | 205 |
Approved indications
- Hairy cell leukemia
Common side effects
- Infusion related reactions
- Edema
- Nausea
- Fatigue
- Headache
- Pyrexia
- Constipation
- Anemia
- Diarrhea
- Fluid retention
- Edema peripheral
- Face edema
Serious adverse events
- HUS (Hemolytic Uremic Syndrome)
- Febrile neutropenia
- Hypertension
- Grade 3 Edema
- Pericardial effusion
- Ascites
- Fluid overload
- Conjunctival hemorrhage
- Conjunctivitis
- Ocular discharge
Key clinical trials
- Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia (PHASE1)
- US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
- Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL) (PHASE1)
- Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities
- An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia
- Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (PHASE3)
- A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia (PHASE1)
- Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL) (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lumoxiti CI brief — competitive landscape report
- Lumoxiti updates RSS · CI watch RSS
- AstraZeneca portfolio CI