FDA approves AstraZeneca’s Lumoxiti for hairy cell leukaemia (HCL)

The FDA granted the CD22-directed cytotoxin Fast Track and Priority review designations as well as Orphan Drug designation which is intended to provide incentives to assist and encourage the development of drugs for rare diseases.

The drug’s efficacy was shown in a clinical study of 80 patients who had previously been treated for HCL. The most common side effects included injection-related reactions, edema, nausea, fatigue, headache, fever, constipation, anemia, and diarrhoea.

Dr Richard Pazdur, Director of the FDA's Office of Hematology and Oncology Products, commented in a statement that: "This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer."

Louis Goss

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