Pfizer announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia (ALL).

The designation was based on the results of the Phase 3 INO-VATE ALL trial, which compared inotuzumab ozogamicin to standard of care chemotherapy in 326 adult patients with relapsed or refractory CD22-positive ALL. Topline results from the trial were announced in April 2015 and also presented at the 20th Congress of the European Hematology Association (EHA).

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Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90% of B-cell malignancies, linked to a cytotoxic agent.

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