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Brain Cancer
New Treatment Approach for Newly Diagnosed Glioblastoma Shows Early Signs of Safety, Efficacy
July 28, 2020
In an interview with Targeted Oncology, David Reardon, MD, discussed the background and findings for the phase 1/2 clinical trial of INO-5401 and INO-9012 plus cemiplimab in patients with newly diagnosed glioblastoma.
Interim Analysis Demonstrates Reassuring Toxicity Profile for Glioblastoma
July 24, 2020
David Reardon, MD, discusses the interim results and toxicity with INO-5401 and INO-9012 delivered intramuscularly with electroporation in combination with cemiplimab in patients with newly diagnosed glioblastoma.
FDA Grants Fast Track Designation to Enzastaurin in Newly Diagnosed Glioblastoma
July 17, 2020
Enzastaurin, a first-in-class small molecule, has been granted a Fast Track designation by the FDA for the potential treatment of patients with newly diagnosed glioblastoma.
Expert Says Olutasidenib Appears Safe as Monotherapy in Relapsed/Refractory IDH1-Mutant Gliomas
July 10, 2020
In an interview with Targeted Oncology, Macarena de la Fuente, MD, discussed the findings from a phase 1b/2 study of olutasidenib as treatment of patients with relapsed/refractory IDH1-mutated gliomas, either alone or in combination with azacitidine.
FDA Grants Fast Track Designation to Novel Molecule to Treat Glioblastoma
July 02, 2020
The FDA granted Fast Track designation to the glutamate-binding molecule, anhydrous enol-oxaloacetate, for the treatment of patients with newly diagnosed glioblastoma multiforme.
Rolling BLA Initiated for Omburtamab to Treat Pediatric CNS/Leptomeningeal Metastases
June 30, 2020
A rolling Biologics License Application has been initiated for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma
Investigators Employ a Range of Novel and Established Systemic Therapies for Advanced Glioblastoma
June 22, 2020
Treatment of glioblastoma has seen few advancements since the approval of temozolomide plus radiotherapy in 2005 for newly diagnosed disease. Recently, promising clinical data have reinvigorated hope for novel therapies in this tumor type.
FDA Grants Breakthrough Therapy Designation to Vorasidenib CDx in IDH1/2-Mutant Low-Grade Gliomas
June 15, 2020
"Breakthrough designation for the companion diagnostic is a big step forward in our endeavor to ensure that more clinicians can have quicker access to comprehensive genomic information."
Berubicin Granted Orphan Drug Designation for Treatment of Malignant Gliomas
June 12, 2020
Glioblastoma currently has a dismal survival rate of only 14.6 months from its diagnosis. We believe berubicin, which based on limited clinical data appears to be the first anthracycline to cross over the blood-brain barrier in adults, provides a potentially novel therapy for the treatment of malignant gliomas.
FDA Grants Priority Review to Naxitamab in R/R High-Risk Neuroblastoma
June 02, 2020
"We believe that the FDA’s acceptance of our BLA for priority review of our first leading antibody compound, naxitamab, is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that naxitamab if approved, can address a significant unmet medical need for [patients] with relapsed/refractory high-risk neuroblastoma."