Ofatumumab FDA Approved to Treat Chronic Lymphocytic Leukemia


The recent approval of Ofatumumab by the FDA is exciting news for the medical and pharmaceutical world. As a monoclonal antibody used to treat chronic lymphocytic leukemia, Ofatumumab garnished a Supplemental Biologic License Application in late April 2014. Known as the brand name drug Arzerra, which is marketed by both GlaxoSmithKline and Genmab this unique anti-cancer treatment is a CD20-directed monoclonal antibody.

CD20

Ofatumumab is aimed at patients with chronic lymphocytic leukemia who have yet to be treated, and who cannot tolerate fludarabine-based therapy. The administration of the I.V. injection of Ofatumumab is best given in conjunction with Chlorambucil. Positive study results were disseminated from a Phase 3 trial coined COMLEMENT 1. This comprehensive study overwhelmingly showed that patients who were dosed with a combination of Ofatumumab and Chlorambucil demonstrated a significantly greater progression- free survival rate as compared to the patients who received Chlorambucil alone.

The intravenous infusion of Ofatumumab is typically dispensed in a 12 dose series, and each infusion can take between one and three hours to complete. The first 8 of the 12 doses are given one week apart, and the last 4 doses of the 12 are given four weeks apart. Patients at a high risk for hepatitis B are often administered antivirals adjunctively with treatment of Ofatumumab. Adverse effects were uncommon and included upper abdominal pain, herpes simplex, asthenia, respiratory tract infections, neutropenia and leukopenia. As an extremely common form of cancer affecting adults’ worldwide chronic lymphocytic leukemia affects a great number of people. Continued development of novel and more effectual treatments for this refractory form of leukemia are urgent.

LGM Pharma provides the API Ofatumumab, CAS # 679818-59-8 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

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