FDA Grants Moxetumomab Pasudotox Priority Review for Hairy Cell Leukemia

April 3, 2018 – The FDA has granted a priority review to moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, according to AstraZeneca (MedImmune), the developer of the anti-CD22 recombinant immunotoxin. The application for moxetumomab pasudotox is based on the phase III 1053 study, which achieved the primary endpoint of durable complete response in adult patients with … (leggi tutto)