Pfizer announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the Biologics License Application (BLA) for inotuzumab ozogamicin for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults.
The BLA submission is based on positive data from the INO-VATE 1022 study, a Phase 3 trial evaluating inotuzumab ozogamicin vs. standard of care chemotherapy in 326 adults with relapsed or refractory B-cell ALL.
The primary endpoints included complete response with or without hematologic remission (CR/CRi) and overall survival (OS). The most common adverse events observed were cytopenias, including febrile neutropenia, nausea, headache, and pyrexia. Detailed study findings were published in The New England Journal of Medicine in June 2016.
Inotuzumab ozogamicin previously received Breakthrough Therapy designation for ALL in October 2015. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 2017 to make a decision on the BLA.
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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