US FDA accepts regulatory submission for Pfizer’s inotuzumab ozogamicin

US-based pharmaceutical company Pfizer’s biologics licence application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted priority review by the US Food and Drug Administration (FDA).

Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) that comprises a monoclonal antibody (mAb) targeting CD22, and is currently being evaluated for the treatment of adult patients affected with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

Pfizer global product development oncology chief development officer Dr Mace Rothenberg said: "ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease.

"Based on the positive results of the INO-VATE 1022 Phase III trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL."

In October 2015, Pfizer’s Inotuzumab ozogamicin received breakthrough therapy designation from the US FDA, while the Prescription Drug User Fee Act (PDUFA) goal date for a decision to be taken by the FDA is slated for August this year.

A marketing authorisation application (MAA) for inotuzumab ozogamicin for the treatment of patients with relapsed or refractory B-cell precursor is currently under review by the European Medicines Agency (EMA).

This year, it is estimated that 5,970 cases of ALL will be diagnosed in the US, with every two in five cases occurring in adults.