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 

Innate licensed the US and EU rights to AstraZeneca’s Lumoxiti in October 2018.  In December 2020, Innate announced it will return the US and EU commercialization rights of Lumoxiti to AstraZeneca*.

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.