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.
Patients may gain access to unapproved or investigational medicines through clinical trials or early access programs (EAPs) before they are approved by regulatory authorities. EAPs allow a limited group of patients, who meet specific criteria, to have access to a specific investigational medicine. EAPs may have a variable designation in the different countries; for example, they are called authorization for temporary use (ATU) in France.
An EAP for Lumoxiti is available in France, Germany, UK, Spain, Italy and Switzerland. Lumoxiti is accessible through an ATU in France. For further information about this program in your area, please contact our Medical Affairs team at email@example.com, or by phone at +33(0)977 40 40 41.