AstraZeneca Plc (LON:AZ), a global, science-led biopharmaceutical company, and MedImmune, the company's global biologics research and development arm, announced on Friday the approval by the US Food and Drug Administration (FDA) of Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

Reportedly, Lumoxiti is not recommended in patients with severe renal impairment (CrCl = 29 mL/min).

Lumoxiti was approved under FDA Priority Review. This approval is based on data from the phase III single-arm, open-label '1053' trial of Lumoxiti monotherapy in 80 patients who have received at least two prior therapies, including a purine nucleoside analog. The primary endpoint of the trial was durable complete response.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.