Brain Cancer | Clinical

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.

Quality of Life Maintained After Dose Doubling of Lanreotide Autogel in NETs

March 01, 2021

Treatment with lanreotide autogel in patients with pancreatic neuroendocrine tumors, and midgut neuroendocrine tumors did not cause deterioration in quality-of-life, according to new data from the Phase II CLARINET FORTE study.

Phase 2 Study of VAL-083 Trial Reaches Target Enrollment of Patients With Glioblastoma Multiforme

February 18, 2021

The final patient with glioblastoma multiforme has been enrolled in the ongoing phase 2 clinical trial of VAL-083, which is evaluating the efficacy, safety, and pharmacokinetics of the agent in patients who have been pre-treated with temozolomide prior to disease recurrence.

Zotiraciclib Plus Temozolomide Shows Early PFS Benefit in Recurrent Gliomas

January 14, 2021

The investigational, potent, oral CDK9 inhibitor, zotiraciclib in combination with temozolomide, demonstrated early improvement in progression-free survival as treatment of patients with recurrent high-grade gliomas, meeting the primary end point of the phase 1B 17-C-0009 trial clinical trial.

Enzastaurin Dosed in First Phase 3 Study of Newly Diagnosed Glioblastoma Multiforme

January 11, 2021

The first patient with newly diagnosed glioblastoma multiforme has been dosed with the first-in-class small molecule enzastaurin in combination with temozolomide and radiotherapy in the phase 3 ENGAGE clinical trial with an aim of determining the overall survival outcome of the drug in this patient population.

FDA Approves Naxitamab for Treatment of Relapsed/Refractory High-Risk Neuroblastoma

November 25, 2020

The FDA has granted approval to the naxitamab as treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease on prior treatment.