FDA approves Besponsa for pediatric ALL patients
The agency cleared inotuzumab ozogamicin for children 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia on March 6, 2024.
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.1
The source does not provide additional detail on trial data, dosing, or prior regulatory history for this drug. No further specifics on clinical outcomes, prescribing information, or previous approvals for other patient populations are included in the available record.
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