Innate Pharma SA said the European Medicines Agency accepted its application seeking approval for its blood cancer treatment Lumoxiti.
The Marseille, France-based drugmaker is seeking approval for Lumoxiti to treat adults with hairy cell leukemia who have received at least two prior systemic therapies — including a purine nucleoside analog — but whose disease returned or did not respond to existing treatment.
Hairy cell leukemia is a rare, chronic and slow-growing leukemia in which the bone marrow overproduces abnormal B cell lymphocytes, a type of white blood cell.
The filing is based on the results of a late stage trial of Lumoxiti, or moxetumomab pasudotox-tdfk, which showed the medicine benefited patients. Innate licensed Lumoxiti from AstraZeneca PLC in October 2018.
The U.S. Food and Drug Administration approved Lumoxiti in September 2018 under its priority review process.