FDA Approval Alert: New Treatment for Relapsed/Refractory ALL


The US Food and Drug Administration (FDA) has approved an injection for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).


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Outcomes of Treating ALL With Inotuzumab Ozogamicin

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Inotuzumab ozogamicin (Besponsa, Pfizer) is a targeted therapy designed to bind to B-cell ALL cancer cells that express the CD22 antigen.

The approval came following results of a trial that tested the safety and efficacy of inotuzumab ozogamicin in 326 patients with relapsed or refractory disease who had received no more than two prior treatments. Patients were randomized to receive either inotuzumab ozogamicin or an alternative chemotherapy regimen. Among the 218 evaluated patients, 35.8% who received inotuzumab ozogamicin experienced complete remission for a median of 8.0 months, whereas 17.4% of those who received alternative chemotherapy experienced complete remission for a median of 4.9 months.

Side effects associated with inotuzumab ozogamicin include thrombocytopenia, neutropenia, leukopenia, infection, anemia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, liver damage, abdominal pain, and hyperbilirubinemia.—Zachary Bessette