FDA approves inotuzumab ozogamicin for pediatric ALL patients
“In all patients, 22/53 (42%, 95% CI: 28.1, 55.9%) achieved CR and the median duration of CR was 8.2 months (95% CI: 2.6, NE). The MRD negativity rate in patients with CR was 21/22 [95.5% (95% CI: 77.2, 99.9)] based on flow cytometry, and 19/22 [86.4% (95% CI: 65.1, 97.1] based on RQ-PCR. The most common adverse reactions (≥20%), including laboratory abnormalities, were thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.”
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