The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.

RELAPSED OR REFRACTORY ALL — Induction chemotherapy induces a complete remission in 60-90% of adults with newly-diagnosed ALL, but most of these patients will subsequently relapse. The goal for patients who do not respond to induction therapy and those who respond initially and then relapse is to achieve a complete remission, or close to it, in order to proceed to an allogeneic hematopoietic cell transplant (HCT), which can be curative.1

MECHANISM OF ACTION — The antibody-drug conjugate binds to CD22, which ... more      

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