FDA reviewing AstraZeneca hairy cell leukemia therapy

The MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA accepted and granted Priority Review to a BLA for moxetumomab pasudotox to treat hairy cell leukemia in adults who have received at least two prior therapies. The PDUFA date is in 3Q18.

The company said in November that the therapy met the primary endpoint of durable complete response in a Phase III trial. Data are to be presented at a forthcoming medical meeting...