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Ref Type
PMID
Authors
Title Lumoxiti (moxetumomab pasudotox-tdfk) FDA Drug Label
Journal
Vol
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761104
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Moxetumomab pasudotox-tdfk Lumoxiti CAT-8015 Lumoxiti (moxetumomab pasudotox-tdfk) is an immunotoxin targeting CD22-positive tumor cells (PMID: 30030507). Lumoxiti (moxetumomab pasudotox-tdfk) is FDA approved for use in patients with relapsed or refractory hairy cell leukemia (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown hairy cell leukemia not applicable Moxetumomab pasudotox-tdfk FDA approved Actionable In a Phase III trial that supported FDA approval, Lumoxiti (moxetumomab pasudotox-tdfk) treatment resulted in durable complete response in 30% (24/80), complete response in 41% (33/80), objective response (complete response and partial response) in 75% (60/80), and hematologic remission in 80% (64/80) of patients with relapsed or refractory hairy cell leukemia who had more than 2 prior systemic therapies (PMID: 30030507; NCT01829711). 30030507 detail...