FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Pediatric Cancer
Lymphoseek Approval Expanded to Pediatric Patients
The approval was based on data from a phase 2 trial that assessed Lymphoseek in pediatric patients with melanoma, RMS, or other solid tumors.
Pedmark Receives Priority Review for Prevention of Cisplatin-Induced Ototoxicity
The application is supported by data from 2 pivotal open-label, randomized phase 3 trials (SIOPEL 6 and ACCL0431), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss.
Fertility Treatment and Childhood Cancer Risk: What’s the Link?
Of all types of fertility treatment examined, the only one that significantly increased the risk of cancer in children was frozen embryo transfer.
Asparlas Approved for Acute Lymphoblastic Leukemia in Peds, Young Adults
Compared with other pegaspargase products (Oncaspar [pegaspargase], Erwinaze [asparaginase Erwinia chrysanthemi]), Asparlas allows for a longer interval between doses.
FDA to Review Sprycel as Add-On to Chemotherapy in Pediatric Ph+ ALL
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.
Peripheral Neuropathy Common in Childhood Cancer Survivors
Clinical abnormalities consistent with peripheral neuropathy were common and were observed in about half (50.5%) of those treated with neurotoxic chemotherapy
Treatment for Rare Pediatric Cancer Granted Orphan Drug Designation
CLR 131 is an investigational radioiodinated Phospholipid Drug Conjugate (PDC) drug candidate that delivers cytotoxic radiation directly and selectively to malignant cells.
Checklist Developed for Parents of Children With Cancer
“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.
FDA Fast Tracks Pedmark for Prevention of Cisplatin-Induced Ototoxicity
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.
