FDA Accepts BLA for AstraZeneca’s Hairy Cell Leukemia Candidate

The FDA accepted a BLA for AstraZeneca and MedImmune’s hairy cell leukemia treatment Moxetumomab pasudotox, indicated for patients who have received at least two prior lines of therapy.

The investigational drug met its primary endpoint of durable complete response in adults with relapsed or refractory HCL.

The FDA set the drug’s PDUFA decision date for the third quarter of 2018.