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# Pfizer’s Besponsa Expanded Use in Pediatric Leukemia
- URL: https://www.fdaweb.com/pfizers-besponsa-expanded-use-in-pediatric-leukemia/
- Published: 2024-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:24:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156495

FDA has approved Pfizer’s Besponsa (inotuzumab ozogamicin) for an expanded indication — treating pediatric patients aged one year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). The drug was [originally approved](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inotuzumab-ozogamicin-relapsed-or-refractory-b-cell-precursor-all?ref=fdaweb.com) in 2017 for the same indication in adults.

The expanded use was [approved](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inotuzumab-ozogamicin-pediatric-patients-acute-lymphoblastic-leukemia?ref=fdaweb.com) based on efficacy data from a multicenter, single-arm, open-label study in 53 pediatric patients with relapsed or refractory CD22-positive B-cell precursor ALL, an FDA release says. “In all patients, 22/53 (42%, 95% CI: 28.1, 55.9%) achieved complete remission (CR) and the median duration of CR was 8.2 months (95% CI: 2.6, NE),” it says.

Regarding safety, the agency says the most common adverse reactions were thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.