PFE - FDA Approves Pfizer's Leukemia Drug For Kids As Old As One Year | Benzinga
Wednesday, the FDA approved Pfizer Inc’s (NYSE:PFE) inotuzumab ozogamicin (Besponsa) for pediatric patients one year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
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Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients.
Two dose levels were evaluated: An initial dose of 1.4 mg/m2/cycle in 12 patients and 1.8 ...