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Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia

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Pfizer announced that the investigational antibody-drug conjugate inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL).

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

Inotuzumab ozogamicin is an investigational antibody-drug conjugate comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on approximately 90% of B-cell malignancies) linked to a cytotoxic agent (a calicheamicin). When inotuzumab ozogamicin binds to the CD22 antigen on malignant B cells, it is internalized into the cell, where the cytotoxin calicheamicin is released to destroy the cell.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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