Pfizer’s ADC Gets Breakthrough Therapy StatusBy
Pfizer’s investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL). Breakthrough therapy designation is a FDA mechanisms intended to expedite the development and review of a potential new medicine that treats a serious or life-threatening disease where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies
Inotuzumab ozogamicin is comprised of a monoclonal antibody (mAb) targeting CD22,9 a cell surface antigen expressed on approximately 90% of B-cell malignancies linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell, where the cytotoxic agent, calicheamicin, is released to destroy the cell.
Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing, clinical development, and commercialization activities for this molecule.