Lumoxiti, a marketed product, is a CD22-directed immunotoxin and a first-in-class treatment in the US for certain patients with relapsed or refractory (r/r) hairy cell leukemia. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).
Lumoxiti received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for the treatment of r/r HCL. In 2020, the EMA Committee for Medicinal Products for Human Use (CHMP) recommended a positive opinion under exceptional circumstances for Lumoxiti.
More information about Lumoxiti in the US, including Boxed Warning and full Safety Information, is available at https://www.lumoxiti.com/
The Companies will develop a transition plan with the goal of returning full commercialization responsibilities to AstraZeneca in 2021. AstraZeneca will remain the marketing authorization applicant for the EU filing.
*Lumoxiti is licensed from MedImmune, a subsidiary of AstraZeneca.