BRAIN CANCER

An orphan drug designation and a fast track designation have been granted by the FDA to a novel sonodynamic therapy platform as a potential treatment for patients with recurrent glioblastoma and other malignant gliomas.

Rare pediatric disease designation has been awarded to paxalisib for the treatment of patients with atypical rhabdoid or teratoid tumors in rare and highly-aggressive childhood brain cancer.

Findings from 2 studies suggest that long-term survival is possible in a significant proportion of patients with a 1p/19q co-deleted oligodendroglioma.

An investigational bivalent gB/pp65 immunotherapeutic vaccine candidate has been granted orphan drug designation by the FDA for the treatment of patients with glioblastoma.

Fast track designation has been granted by the FDA to dianhydrogalactitol for the treatment of patients with newly-diagnosed unmethylated glioblastoma.

Paxalisib has been granted orphan drug designation by the FDA for the treatment of patients with atypical rhabdoid or teratoid tumors in rare and aggressive childhood brain cancer.

Pediatric low-grade glioma is the most common type of brain tumor found in children with cancer, and there are currently no approved treatments or standard of care to combat it.

The phase 3 REVELATE trial investigating potential use of 18F-fluciclovine in detecting recurrent brain metastases after radiotherapy has completed patient accrual.

Interim clinical data from a phase 1/2 clinical trial of ST101 in refractory solid tumors leads to the expansion of the phase 2 glioblastoma arm of the study.

According to Eric Bouffet, MD, results from a phase 2 study presented during the 2022 ASCO Annual Meeting show how important it is to document as early as possible the molecular alterations that are present in this type of tumor.

Dafrafenib plus trametinib demonstrated greatly improved response rates and progression-free survival in pediatric patients with BRAF V600-mutated gliomas.

The combination of naxitamab combined with irinotecan, temozolomide, and sargramostim induced responses in patients with high-risk neuroblastoma.

After identifying a survival disparity among non-White Hispanic patients with pediatric neuroblastoma, investigators will next examine the interaction of survival and race, ethnicity, and poverty, acknowledging the intersectionality of these factors due to structural racism in the United States.

In an interview with Targeted Oncology, Stephen M. Karlovits, MD, discussed key developments that researchers have made in the primary brain tumor treatment landscape in recent years and upcoming trials with potential to improve outcomes for patients.

The FDA has issued a complete response letter to surufatinib for the treatment of a pancreatic and extra-pancreatic neuroendocrine tumors.

Evidence for on-target activity of temferon has been demonstrated in patients with glioblastoma, according to the phase 1/2a TEM-GBM study.

For the second time, an application for approval has been submitted for the FDA for I-omburtamab for the treatment of pediatric patients with central nervous system or leptomeningeal metastasis from neuroblastoma.

The FDA has given the targeted inhibitor alrizomadlin a rare pediatric disease designation for the treatment of neuroblastoma.

In an interview with Targeted Oncology, David Siegel, MD, explained the many changes seen in pediatric cancer mortality and survival over the past 40 years.

After treatment with SurVaxM in patients with newly diagnosed glioblastoma significantly improved survival, investigators are continuing the evaluation of the agent in a phase 2b clinical trial.

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.