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Brain Cancer | Clinical
Safety, Efficacy Results Boost the Use of NKT Cells in Pediatric Neuroblastoma
July 11, 2021
Safety and efficacy data for natural killer T (NKT) cells bolster the use of this cellular therapy in patients with stage IV relapsed/refractory neuroblastoma, according to early findings.
Overall Survival Improved With 177 Lu-Dotatate for Patients With Progressive Midgut NETs
July 02, 2021
Final overall survival and long-term safety results of the phase 3 NETTER-1 trial were presented during the World Congress on Gastrointestinal Cancer 2021.
FDA Approval for Surufatinib Under Consideration for Advanced NETs
July 01, 2021
The FDA has accepted the filing of a new drug application for surufatinib to be indicated as treatment of patients with advanced neuroendocrine tumors. The FDA set a Prescription Drug User Fee Act target action date of April 30, 2022.
Safety/Feasibility of CAR T-Cell Therapy Being Investigated in Brain Tumors
May 18, 2021
The first patient has been dosed in a study designed to evaluate the safety and feasibility of IL13Rα2 chimeric antigen receptor T cell therapy for the treatment of leptomeningeal brain tumors, such as glioblastoma, ependymoma, and medulloblastoma.
FDA Approval Sought for Surufatinib in Pancreatic and Extra-Pancreatic NETs
May 03, 2021
A rolling submission of a new drug application to the FDA has been initiated for surufatinib as a potential treatment option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.
FDA Grants Rare Pediatric Disease Designation to WP1066 for Patients With Ependymoma
April 14, 2021
The FDA has granted a rare pediatric disease designation to the novel p-STAT3 inhibitor WP1066 for the treatment of patients with the rare brain and spinal cord malignancy, ependymoma.
CYNK-001 Granted Orphan Drug Designation for Treatment of Malignant Gliomas
April 13, 2021
The FDA has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.
FDA Advises on Termination of ERC1671 Clinical Trial in Recurrent Glioblastoma
April 07, 2021
The FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.
FDA Grants NK Cell Therapy Fast Track Designation for Recurrent GBM
March 18, 2021
The FDA has granted CYNK-001, a natural killer cell therapy, with a fast track designation for the treatment of adult patients with recurrent glioblastoma multiforme, according to a press release from developer Celularity.
FDA Grants Orphan Drug Designation to Novel CDK2/4/6 Inhibitor in Malignant Gliomas
March 11, 2021
The FDA granted orphan drug designation to the CDK2/4/6 inhibitor, NUV-422, for the treatment of patients with malignant gliomas.