FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6^th, 2010.

Chronic lymphocytic leukemia is the most common form of leukemia in the United States. It is estimated that 108,437 persons in the USA are living with or are in remission from CLL. Though its cause remains unknown, it is characterized by the proliferation of B lymphocytes that migrate into the lymph nodes, spleen and liver and invade the bone marrow and blood. This can lead to anemia and/or thrombocytopenia (drop in platelet count) and induces an immunocompromised state in patients, thus increasing the risk of severe infections. Chronic lymphocytic leukemia is rare in patients under 55 years (only 11%) and incidence rises rapidly with age above 55 years. The median age at diagnosis is 72 years. Median survival is about 10 years but varies from less than 3 years to a normal life expectancy depending on prognostic factors.

At present, there is no true curative approach in the vast majority of patients with CLL.