FDA Priority Review for AZN new drug



The FDA accepts under Priority Review AstraZeneca’s (NYSE:AZN) marketing application seeking approval for moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least two prior lines of therapy. The agency’s action date is in Q3.

Orphan Drug-tagged moxetumomab pasudotox is an anti-CD22 recombinant immunotoxin. It consists of an antibody that binds to protein found on B-lymphocytes (CD22) that is fused to a toxin. Once the molecule is internalized by the cancer cell, the toxin leads to cell death by inhibiting protein translation. Specifically, the cell cannot read the information from messenger RNA so it cannot build proteins and dies.