FDA accepts filing for Pfizer's investigational leukemia drug

A Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the US Food and Drug Administration (FDA), said its developer, US pharma giant Pfizer (NYSE: PFE).

Inotuzumab ozogamicin, which in 2013 was effectively dumped by Pfizer after a failed Phase III study in non-Hodgkin lymphoma (NHL) but later brought back to life, is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2017.