Regulatory Affairs

FDA grants priority review to Pfizer's antibody-drug conjugate for ALL

PBR Staff Writer Published 22 February 2017

The US Food and Drug Administration (FDA) has granted a priority review designation to Pfizer's anti-CD22 antibody-drug conjugate inotuzumab ozogamicin to treat patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Currently, Inotuzumab ozogamicin is being assessed for treatment of adult patients with acute lymphoblastic leukemia (ALL) both in relapsed and refractory B-cell precursor forms.

The drug will now be reviewed within six months from the date of acceptance of filing instead of the original timeframe of 10 months owing to the fast track status. Priority Review is granted to drug candidates that may provide significant advances in treatment or may offer a treatment for which lacks sufficient therapies.

The FDA decision on the inotuzumab ozogamicin’s acceptance for ALL is slated for August this year.

Pfizer global product development, oncology chief development officer Mace Rothenberg, MD 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 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.”

The drug was granted the Breakthrough Therapy designation by the FDA in October 2015 for ALL.

In Europe, inotuzumab ozogamicin’s Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA) in the same patient population.

Based on the Phase 3 INO-VATE 1022 trial results, the submissions were made for inotuzumab ozogamicin which was trialed against standard of care chemotherapy.

The trial met the two independent primary endpoints defined as complete response with or without hematologic remission (CR/CRi) and overall survival (OS).

An investigational antibody-drug conjugate (ADC), inotuzumab ozogamicin comprises a monoclonal antibody (mAb) that targets cell surface antigen CD22 responsible for the presence of 90% of B-cell tumors, linked to a cytotoxic agent.