Brain Cancer | Clinical

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.

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.