BRAIN CANCER

A real-world guide to best practices in treating neuroendocrine tumors can improve patient outcomes.

The FDA’s orphan drug designation granted to silmitasertib for medulloblastoma marks the agent’s second such designation.

Following an orphan drug designation earlier in 2021, NUV-422 has been granted a fast track designation for the treatment of high-grade gliomas.

The considerations investigators must take into account when designing clinical trials include patient population, previous therapies, assessment of the central nervous system, end points, and leptomeningeal disease, according to the new guidelines.

ST101, an agent being investigated in a phase 1/2 clinical trial, has been granted fast track designation from the FDA for the treatment of patients with glioblastoma multiforme.

Arturo Loaiza-Bonilla, MD, MSEd, FACP, discussed recent trials and advances in neuroendocrine cancer research in an interview with Targeted Oncology for World Neuroendocrine Cancer Day.

From precision radiotherapeutics to small molecule inhibitors, Scott Paulson, MD, discusses a new array of pharmacological treatments for World Neuroendocrine Cancer Day.

The phase 3 COMPOSE trial is the second trial to look at 177Lu-edotreotide in somatostatin receptor-positive disease.

The designation is based on a phase 1/2 study of the agent in patients 3-19 years of age.

Alpha DaRT, an intraumoral conformal alpha-irradiation strategy, has been granted a second breakthrough device designation by the FDA.

Compared with historic controls, the use of adjuvant VAL-083 after chemoradiotherapy and temozolomide may improve outcomes for select patients with glioblastoma multiforme.

During the past 4 decades, glioblastoma has remained a cancer with one of the worst prognoses and is among the most debilitating.

LP-184 is moving forward in the course of development and was granted an orphan drug designation by the FDA.

For patients with neuroendocrine tumors, the chances of dying of cancer were higher than dying of other causes, but mortality largely varies by primary tumor site.

While brain tumor rates are declining, 5-year survival remains low at 36%. Incidence rates of adult brain tumors are decreasing; however, 5-year survival rates remain low.

The FDA has granted fast track designation to the highly selective inhibitor of casein kinase 2 inhibitor, silmitasertib for the treatment of patients with recurrent sonic hedgehog-driven medulloblastoma.

The immune biology of the neuroblastoma microenvironment is an emerging field.

The benefit of using a drug off-label is that it may provide the best available intervention for a patient with no other option.

Rising interest in SSTR2-targeted radiopharmaceuticals has led to the evaluation of numerous ways to optimize peptide receptor radionuclide therapy in patients with neuroendocrine tumors.

DAY101, an investigational, oral, brain-penetrant, and highly selective type II pan-RAF kinase inhibitor for the treatment of rare, pediatric low-grade glioma, was granted a rare pediatric disease designation by the FDA.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The FDA granted orphan drug designation to the CDK2/4/6 inhibitor, NUV-422, for the treatment of patients with malignant gliomas.