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Moxetumomab pasudotox

Generic Name
Moxetumomab pasudotox
Brand Names
Lumoxiti
Drug Type
Biotech
Chemical Formula
-
CAS Number
1020748-57-5
Unique Ingredient Identifier
2NDX4B6N8F
Background

CD22 is a lineage-restricted B-cell antigen that is expressed solely in on B-chronic lymphocytic leukemia, hairy cell leukemia, acute lymphocytic leukemiathe and Burkitt's lymphoma. The predecessor of Moxetumab pasudotox (MxP), named BL22, was first created based on the antibody RFB4 which specifically binds to CD22. This antibody was used to generate a recombinant immunotoxin in which a stabilized Fv segment by a disulfide bond is fused to the Pseudomonas exotoxin A (PE38) which does not have the cell-binding portion.

MxP appears as an improved form of BL22 by the mutation of the Fv region and the antibody phage-displayed. As well the residues SSY in the heavy chain are mutated to THW. It was developed by Astra Zeneca and FDA approved on September 13, 2018, after being granted the status of Fast Track, Priority Review and Orphan Drug designations.

Indication

MxP is indicated 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. The use of this drug is not recommended in patients with severe renal impairment (CrCl < 29 ml/min).

HCL is an uncommon type of lymphocytic leukemia that starts in B cells or B lymphocytes. It is characterized by an accumulation of abnormal B lymphocytes. HCL is called "hairy" as it produces hair-like projections in the surface of the cancer cells. A usual symptom in people having HCL is the presence of splenomegaly and less often hepatomegaly.

Associated Conditions
Relapsed/Refractory Hairy Cell Leukemia
Associated Therapies
-

Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia

Phase 1
Active, not recruiting
Conditions
Hairy Cell Leukemia
Interventions
First Posted Date
2019-01-16
Last Posted Date
2024-07-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
18
Registration Number
NCT03805932
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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