Posted by Michael Wonder on 03 Apr 2018
US FDA accepts biologics license application for moxetumomab pasudotox in hairy cell leukaemia
3 April 2018 - Moxetumomab pasudotox application granted priority review.
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US FDA has accepted the biologics license application for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy. The FDA has granted the moxetumomab pasudotox application priority review status with a Prescription Drug User Fee Act date set for the third quarter of 2018.
The Phase III (‘1053’) moxetumomab pasudotox clinical trial met its primary endpoint of durable complete response in adult patients with relapsed or refractory HCL, for which there is currently no established standard of care and few treatments available.[i],[ii] Results from the 1053 Phase III trial will be presented at a forthcoming medical meeting.
