ARZERRA
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). It is used as a first-line therapy in combination with chlorambucil for patients who cannot tolerate fludarabine-based regimens, and in combination with fludarabine and cyclophosphamide for relapsed disease. The medication is also approved for extended treatment following a response to previous therapies and for cases that are refractory to fludarabine and alemtuzumab.
How ARZERRA Works
Ofatumumab targets the CD20 molecule expressed on the surface of normal and malignant B lymphocytes. The antibody binds to the extracellular loops of CD20 and remains on the cell surface without being internalized or shed. This binding allows the drug to mediate immune effector functions, resulting in the lysis of B cells. Suggested mechanisms for this cell death include complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity.
Details
- Status
- Prescription
- First Approved
- 2009-10-26
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ARZERRA Approval History
What ARZERRA Treats
4 indicationsARZERRA is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Previously untreated chronic lymphocytic leukemia in combination with chlorambucil for patients for whom fludarabine-based therapy is considered inappropriate
- Relapsed chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide
- Extended treatment of recurrent or progressive chronic lymphocytic leukemia in patients with complete or partial response after at least two lines of therapy
- Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab
ARZERRA Boxed Warning
HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions (5.2)] . Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautio...
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnings and Precautions (5.2)] . Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA [see Warnings and Precautions (5.4)] . WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.4 )
ARZERRA Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
ARZERRA Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARZERRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Chronic Lymphocytic Leukemia (CLL) ARZERRA (ofatumumab) is indicated: in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate [see Clinical Studies ] in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL [see Clinical Studies ] for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL [see Clinical Studies ] for the treatment of patients with CLL refractory to flu...
WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ARZERRA ® , in some cases resulting in fulminant hepatitis, hepatic failure, and death [see Warnin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.