The sBLA contains data from the Phase 2 CA180-372 trial evaluating Sprycel as an add-on to chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
Clinical abnormalities consistent with peripheral neuropathy were common and were observed in about half (50.5%) of those treated with neurotoxic chemotherapy
CLR 131 is an investigational radioiodinated Phospholipid Drug Conjugate (PDC) drug candidate that delivers cytotoxic radiation directly and selectively to malignant cells.
"Focusing education on the most important topics before the first hospital discharge and only teaching additional topics if parents have time to understand can help parents remember the important, relevant information," the authors said.
The Clinical Oncology Group Protocol ACCL0431 trial enrolled 125 pediatric patients newly diagnosed with a germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.