The approval was based on the Phase 3, randomized, double-blind, placebo-controlled EXIST-3 (EXamining everolimus In a Study of TSC) study which evaluated adjunctive Afinitor Disperz (low exposure: 3-7ng/mL; high exposure: 9-15ng/mL) in patients with treatment-resistant TSC-associated partial-onset seizures, defined as inadequate control of partial-onset seizures despite use of ≥2 sequential regimens of single or combined anti-epileptic drugs.
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.
Currently, entrectinib is being evaluated in the global, multicenter, open-label, potentially registration-enabling Phase 2 STARTRK-2 trial (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases)
The approval was supported by three prospective studies that showed aminolevulinic acid-induced fluorescence was highly predictive for visualizing malignant tissue as verified by histopathology of biopsied fluorescent tissue.
The researchers found that the median progression-free survival was 6.7 and 4.0 months for patients treated with TTFields/TMZ and TMZ alone, respectively.
The Breakthrough Therapy designation was supported by safety, efficacy (durable, complete or partial tumor shrinkage) and patient survival data from three Phase 1 studies involving 126 patients with recurrent brain cancer.
The Food and Drug Administration (FDA) has approved an update to the labeling for Noxafil (posaconazole; Merck) regarding an interaction with vincristine.
Amerigen announced that the FDA has granted final approval to the Abbreviated New Drug Application (ANDA) for Temozolomide Capsules, the generic version of Merck's Temodar.
The Food and Drug Administration (FDA) is informing that a counterfeit version of BiCNU (carmustine for injection; Heritage) 100mg has been identified in some foreign countries.
The Food and Drug Administration (FDA) has granted Orphan Drug designation for VAL-083 (DelMar) in the treatment of medulloblastoma, the most common malignant pediatric brain cancer.
Overall rates of cancer and cancer mortality in the United States continue to decline, according to the Annual Report to the Nation on the Status of Cancer.
Patients with respiratory allergies, asthma, and eczema may be less likely to develop a glioma, according to a study published in the February issue of Cancer Epidemiology, Biomarkers & Prevention.
An open-label, phase 2 trial showed acceptable toxicity and survival rates for the use of proton radiotherapy in children with medulloblastoma.
The FDA has granted Orphan Drug designation to marizomib (Triphase Accelerator) for the treatment of malignant glioma, an aggressive form of brain cancer with a significant unmet need due to its poor prognosis.
The U.S. Food and Drug Administration on Monday expanded its approval for the Optune device to include newly diagnosed glioblastoma multiforme.
A new article published in Neurology suggests that being overweight or obese may be linked to an increased risk of developing meningioma, a type of brain tumor.
Merck announced a voluntary recall of Temodar (temozolomide) and its generic Temozolomide (Sandoz) capsules due to the potential for the bottle caps to be cracked.
Amneal announced the recent launch of four new products: Tobramycin Inhalation Solution, Memantine HCl Immediate Release Tablets, Temozolomide Capsules, and Divalproex Sodium Extended Release Tablets.
The Food and Drug Administration (FDA) has granted Fast Track status to Toca 511 and Toca FC for the treatment of recurrent high grade glioma, which includes glioblastoma and anaplastic astrocytoma.
Therapeutic anticoagulation is safe for treating venous thromboembolism in patients with cancer that has metastasized to the brain, according to new research.
Targeted radiation in the treatment of brain metastases leads to less cognitive damage than radiation for the entire brain, while survival is similar, researchers reported at the annual meeting of the American Society of Clinical Oncology. In a second study, researchers report that early trials of a new form of gene therapy may give hope to patients battling glioblastoma.
A tetanus booster may play a role in priming the immune system to enhance a vaccine for lethal brain tumors, a study published in Nature has shown.
The Food and Drug Administration (FDA) has granted a Rare Pediatric Priority Review Voucher (PPRV) as part of the Biologics License Application (BLA) approval for Unituxin (dinutuximab) for neuroblastoma.