Drug updated on 3/28/2024
Dosage Form | Injection (intravenous; 1 mg) |
Drug Class | CD22-directed cytotoxins |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Summary
- Moxetumomab pasudotox-tdfk (Lumoxiti) is used for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including a purine nucleoside analog.
- Two systematic reviews/meta-analyses were reviewed to gather information about Lumoxiti's effectiveness and safety in treating HCL.
- In one phase 3 trial, moxetumomab pasudotox-tdfk showed an overall response rate of 75% with complete remission observed in 41% of cases among patients with multiple relapses.
- The second studysuggests that moxetumomab pasudotox-tdfk can achieve minimal residual disease-free complete remission without chemotherapy toxicities and should be considered before resorting to splenectomy or when adenopathy develops.
- Compared to other drugs such as Vemurafenib, Bendamustine/Rituximab, Ibrutinib which also show efficacy against HCL; Lumoxiti has been highlighted for its good tolerance profile among patients according to both documents reviewed.
- However, it was noted that high-risk diseases like Hairy Cell Leukemia variant and IGHV4-34+ unmutated HCL require further investigation regarding the use of this drug as per findings from the second document review on Lumoxiti's application in these subgroups.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lumoxiti (moxetumomab pasudotox-tdfk) Prescribing Information. | 2022 | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Management of Relapsed Hairy Cell Leukemia: A Systematic Review of Novel Agents and Targeted Therapies. | 2021 | Clinical Lymphoma, Myeloma & Leukemia |
Treatment of hairy cell leukemia. | 2020 | Expert Review of Hematology |