9 April 2018 - - The biologics license application (BLA) of Wilmington, Delaware-based prescription medicines specialist AstraZeneca-US and its Gaithersburg, Maryland-based global biologics research and development arm MedImmune, for moxetumomab pasudotox has been accepted by the US Food and Drug Administration, the company said.
The FDA has granted the moxetumomab pasudotox BLA priority review status with a Prescription Drug User Fee Act (PDUFA) date set for the third quarter of 2018.
Moxetumomab pasudotox is an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least two prior lines of therapy.
The '1053' Phase III trial, a single-arm, multicenter clinical trial conducted in 80 patients across 34 sites in 14 countries assessing the efficacy, safety, immunogenicity, and pharmacokinetics of moxetumomab pasudotox monotherapy, met its primary endpoint of durable complete response in adult patients with relapsed or refractory HCL.
Moxetumomab pasudotox is composed of a binding portion of an anti-CD22 antibody fused to a toxin. CD22 is a B-lymphocyte restricted transmembrane protein with a higher receptor density in HCL cells relative to normal B cells, making it an attractive therapeutic target for the treatment of this cancer.
MedImmune is pioneering innovative research and exploring novel pathways across oncology; respiratory, cardiovascular, and metabolic diseases; and infection and vaccines.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.
The company has established hematology as one of four key oncology disease areas of focus, and is accelerating development of a broad portfolio of potential blood cancer treatments.
AstraZeneca operates in over 100 countries; its North American headquarters are located in Wilmington, Delaware.