Pfizer's inotuzumab ozogamicin accepted for priority review

The U.S. Food and Drug Administration has accepted Pfizer's Biologics License Application (BLA) for inotuzumab ozogamicin.

The drug, which was granted priority review, is under evaluation for potential use as a treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

“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,” Pfizer wrote in a statement.

The FDA had granted the drug Breakthrough Therapy designation in October 2015. The FDA is set to make a decision on approval by August.

“ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” Dr. Mace Rothenberg, chief development officer of Oncology for Pfizer Global Product Development, said in a statement. “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.”