The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to inotuzumab ozogamicin for the treatment of acute lymphoblastic leukemia (ALL), according to a press release.1

Manufactured by Pfizer, the investigational antibody-drug conjugate was given this designation based on results from the phase 3 INO-VATE ALL trial, which included 326 adult patients with relapsed or refractory CD22-positive ALL.

The trial compared inotuzumab ozogamicin with standard of care chemotherapy, and topline results were announced in April 2015 and presented at the 20th Congress of the European Hematology Association in Austria.

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“Advancing therapies for patients with adult ALL is crucial as only 10% of adults with ALL who relapse after first-line therapy survive five years or more with current treatment options,” said Mace Rothenberg, MD, senior vice president and chief medical officer for Pfizer Oncology.

Inotuzumab ozogamicin is made up of a monoclonal antibody that binds to the CD22 antigen found on approximately 90% of B-cell malignancies. When inotuzumab ozogamicin binds to the antigen, it is internalized into the malignant cell, where the cytotoxic agent calicheamicin is then released to destroy it.


  1. Pfizer’s inotuzumab ozogamicin receives FDA breakthrough therapy designation for acute lymphoblastic leukemia (ALL) [press release]. Pfizer Inc; October 19, 2015. receives_fda_breakthrough_therapy_designation_for_acute_lymphoblastic_leukemia_all. Accessed October 20, 2015.