Pfizer’s Besponsa Expanded Use in Pediatric Leukemia

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 in 2017 for the same indication in adults.

The expanded use was approved 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.