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New Treatment for Chronic Lymphocytic Leukemia


New Treatment for Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL) is a slowly progressing cancer of the blood and bone marrow. Arzerra (ofatumumab) has been approved by the FDA for treating CLL.

Patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy can be prescribed Arzerra.

People older than fifty are mainly affected by CLL. A group of white blood cells known as B-cells that are part of the body’s immune system is the source of CLL. Every year, about ¼ of people diagnosed with CLL die from the disease.


Arzerra is an anti-CD20 monoclonal antibody that targets a membrane-proximal (which means close to the cell surface), small loop epitope, which is a portion of a molecule to which an antibody binds, on the CD20 molecule on B-cells. This epitope isn’t similar to binding sites that are targeted by other CD20 antibodies that are currently available. The CD20 molecule is highly expressed in most B-cell malignancies, making it a key target in CLL therapy.


MECHANISM OF ACTION:

Binding specifically to both the small and large extracellular loops of the CD20 molecule, Arzerra is an anti-CD20 monoclonal antibody. The CD20 molecule is expressed on normal B lymphocytes (pre-B- to mature B-lymphocyte) and on B-cell CLL. The CD20 molecule isn’t internalized following antibody binding and it isn’t shed from the cell surface. The Fc domain of ofatumumab mediates immune effector functions to result in B-cell lysis in vitro, while the Fab domain binds to the CD20 molecule. Complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity has been suggested as the possible mechanisms of cell lysis.

 

Products receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live with fewer side effects of a disease or to live longer. Arzerra was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs.


To confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease, the manufacturer of this medication is currently conducting a clinical trial in CLL patients. This is because the accelerated approval process requires further study of the drug.

The effectiveness of Arzerra has been evaluated in 59 patients with CLL whose disease no longer responded to the available therapies.

Designed for intravenous administration, Arzerra is supplied as a liquid concentrate (20 mg/mL) for dilution. The recommended initial dose and schedule is 12 doses that should be 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).

 

HOW TO ADMINISTER:

  • 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)
  • Dose 3 through 12: Initiate infusion at a rate of 50 mg/hour (25 mL/hour)


The safety of Arzerra has been evaluated in 181 patients in two studies in patients with cancer. Listed below are some of the side effects that are associated with the use of Arzerra:

 

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


However, the side effects of Arzerra aren’t limited to the ones mentioned above.

An increased chance of infections, including PML (progressive multifocal leukoencephalopathy), which is a brain infection that is usually fatal, is the most serious side effect of Arzerra. Before being treated with Arzerra, patients who are at risk of Hepatitis B should be screened. Additionally, during and after completing treatment, patients who have evidence of inactive hepatitis should be monitored for re-activation of the infection.

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Prepared By: Dr. Mehyar Al-Khashroum
Edited By: Miss Araz Kahvedjian




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