Ofatumumab

Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20 molecule encompassing parts of the small and large extracellular loops. Ofatumumab directs the body's immune system to fight normal and cancerous B-cells. Ofatumumab attaches to the CD20 molecule, which is found on the surface of B-cells, the type of cell which becomes cancerous in chronic lymphocytic leukemia (CLL). The CD20 molecule is also found on over 90% of B-cell lymphomas, as well as other lymphoid tumors of B-cell origin. In types of cancer such as these, B-cells can over-proliferate and treatment is needed to reduce their number. Ofatumumab is marketed and developed under a co-development and commercialization agreement with Novartis Pharma AG.

Marketed Indications and Safety

Ofatumumab is approved as Arzerra in certain territories to treat certain chronic lymphocytic leukemia (CLL) indications. On January 22, 2018 it was announced that Novartis intends to transition ofatumumab from commercial availability to limited availability via managed access programs in markets outside the U.S., where applicable and allowed by local regulations. Subsequently, Novartis determined that ofatumumab would remain commercially available in Japan as well as in the U.S. The transition in all other territories is ongoing. 

In the United States ofatumumab solution for infusion is approved in the following indications:

  • in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate;
  • for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL;
  • in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL; 
  • and for CLL patients who are refractory to fludarabine and alemtuzumab.

The overall safety profile of Arzerra in CLL is based on exposure in clinical trials and the post-marketing setting. The most common side effects for Arzerra include adverse events associated with infusion reactions, cytopenias, and infections (lower respiratory tract infection, including pneumonia, upper respiratory tract infection, sepsis, including neutropenic sepsis and septic shock, herpes viral infection, urinary tract infection).

Please consult the full US Prescribing information, including Boxed Warning, and the full European Summary of Product Characteristics for all the labeled safety information for Arzerra.

Clinical Development

A subcutaneous formulation of ofatumumab is being investigated for use in relapsing multiple sclerosis (RMS).

 

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Chronic Lymphocytic Leukemia (CLL) is a cancer in which the bone marrow produces too many white blood cells called lymphocytes.  It is the most common form of leukemia in the western world1 and usually occurs during or after middle age.   Prognosis is relatively good with a five-year survival rate of 64% to 85% in the U.S. and five major European markets.2 Approximately 37,857 new cases of CLL were forecast in the U.S. and the five major European markets in 2015, increasing to 46,110 new cases in 2025.2  

Ofatumumab is being studied in clinical trials, including Investigator Sponsored Studies (ISS); for more information visit clinicaltrials.gov

Ofatumumab is approved as Arzerra in certain territories to treat certain chronic lymphocytic leukemia (CLL) indications; click here for more information.  On January 22, 2018 it was announced that Novartis intends to transition ofatumumab from commercial availability to limited availability via managed access programs in markets outside the U.S., where applicable and allowed by local regulations. Subsequently, Novartis determined that ofatumumab would remain commercially available in Japan as well as in the U.S. The transition in all other territories is ongoing. 


1 GlobalData. EpiCast Report: Chronic Lymphocytic Leukemia Epidemiology Forecast to 2025. Published November 2017.
2 GlobalData. OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018. Published August 2014

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Multiple Sclerosis (MS) is chronic disorder of the central nervous system that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss.  It affects approximately 2.5 million people worldwide1. The most common form of MS, accounting for 85% of cases2 is relapsing remitting MS (RRMS). RRMS is characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery. No progression of neurological impairment is experienced between attacks. It was estimated that there would be 49,387 new cases of MS in the U.S. and 5 major European markets in 2018.1

Phase III studies of a subcutaneous formulation of ofatumumab in relapsing MS are underway. For more information on ofatumumab clinical studies in MS, visit clinicaltrials.gov.


1  GlobalData. EpiCast Report: Multiple Sclerosis - Epidemiology Forecast to 2026. Published November 2017
2 Datamonitor. Multiple Sclerosis Treatment. Published August 2016.


 

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