The FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor ALL. Two dose levels were evaluated: an initial dose of 1.4 mg/m2 per cycle in 12 patients and 1.8 mg/m2 per cycle in 41
MARCH 7, 2024