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).
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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