Arzerra (ofatumumab)


Approval Status
Approved October 2009

Treatment for
chronic lymphocytic leukemia

Hematology , Cancer & Oncology

Arzerra (ofatumumab) is an anti-CD20 monoclonal antibody. It targets a membrane-proximal (close to the cell surface), small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule on B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies.

Arzerra is specifically indicated for the treatment of patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab.

Arzerra is supplied as a liquid concentrate (20 mg/mL) for dilution designed for intravenous administration. The recommended initial dose and schedule is 12 doses administered as follows:
300 mg initial dose (Dose 1), followed 1 week later by
2,000 mg weekly for 7 doses (Doses 2 through 8), followed 4 weeks later by
2,000 mg every 4 weeks for 4 doses (Doses 9 through 12)

Dose 1: Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour)
Dose 2: Initiate infusion at a rate of 24 mg/hour (12 mL/hour)
Doses 3 through 12: Initiate infusion at a rate of 50 mg/hour (25 mL/hour)

FDA Approval
The FDA approval of Arzerra is based on a single-arm, multicenter study in 154 subjects with relapsed or refractory CLL. Arzerra was administered by intravenous infusion according to the following schedule: 300 mg (Week 0), 2,000 mg weekly for 7 infusions (Weeks 1 through 7), and 2,000 mg every 4 weeks for 4 infusions (Weeks 12 through 24). Subjects with CLL refractory to fludarabine and alemtuzumab comprised the efficacy population. The primary endpoint was objective tumor response rate. The overall response rate was 42%, with a median duration of response of 6.5 months. There were no complete responses. Anti-tumor activity was also observed in additional patients in Study 1 and in a multicenter, open-label, dose-escalation study (Study 2) conducted in patients with relapsed or refractory CLL.

Adverse events associated with the use of Arzerra may include, but are not limited to, the following:

  • Neutropenia
  • Pneumonia
  • Pyrexia
  • Cough
  • Diarrhea
  • Anemia
  • Fatigue
  • Dyspnea
  • Rash
  • Nausea
  • Bronchitis
  • Upper respiratory tract infections

Arzerra is an anti-CD20 monoclonal antibody. It binds specifically to both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is expressed on normal B lymphocytes (pre-B- to mature B-lymphocyte) and on B-cell CLL. The CD20 molecule is not shed from the cell surface and is not internalized following antibody binding. The Fab domain of ofatumumab binds to the CD20 molecule and the Fc domain mediates immune effector functions to result in B-cell lysis in vitro. Data suggest that possible mechanisms of cell lysis include complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity.

For additional information regarding Arzerra or chronic lymphocytic leukemia, please visit the Arzerra web page.

Arzerra (ofatumumab) Drug Information

The Arzerra (ofatumumab) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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