BRAIN CANCER

Enzastaurin, a first-in-class small molecule, has been granted a Fast Track designation by the FDA for the potential treatment of patients with newly diagnosed glioblastoma.

In an interview with Targeted Oncology, Macarena de la Fuente, MD, discussed the findings from a phase 1b/2 study of olutasidenib as treatment of patients with relapsed/refractory IDH1-mutated gliomas, either alone or in combination with azacitidine.

The FDA granted Fast Track designation to the glutamate-binding molecule, anhydrous enol-oxaloacetate, for the treatment of patients with newly diagnosed glioblastoma multiforme.

A rolling Biologics License Application has been initiated for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma

Treatment of glioblastoma has seen few advancements since the approval of temozolomide plus radiotherapy in 2005 for newly diagnosed disease. Recently, promising clinical data have reinvigorated hope for novel therapies in this tumor type.

"Breakthrough designation for the companion diagnostic is a big step forward in our endeavor to ensure that more clinicians can have quicker access to comprehensive genomic information."

Glioblastoma currently has a dismal survival rate of only 14.6 months from its diagnosis. We believe berubicin, which based on limited clinical data appears to be the first anthracycline to cross over the blood-brain barrier in adults, provides a potentially novel therapy for the treatment of malignant gliomas.

"We believe that the FDA’s acceptance of our BLA for priority review of our first leading antibody compound, naxitamab, is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that naxitamab if approved, can address a significant unmet medical need for [patients] with relapsed/refractory high-risk neuroblastoma."

Mustafa Khasraw, MD, discusses a follow-up trial to the VERTU study for patient with methylated or unmethylated MGMT glioblastoma who responded well to temozolomide chemotherapy and radiation.

An autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens demonstrated promising survival findings in patients with newly diagnosed glioblastoma, according to updated data from a year-end analysis of an ongoing phase II clinical trial.

The FDA has approved selumetinib for the treatment of pediatric patients, aged 2 years and above, with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

Paxalisib had a strong signal of clinical efficacy in patients with newly diagnosed glioblastoma, according to the interim analysis of a phase II clinical trial. Survival was compared to previous data on the FDA-approved standard of care, temozolomide, from another study. Although the comparison of different studies is not precise, the magnitude of numerical difference in survival provides evidence that this agent may extend life in patients with glioblastoma, Kazia Therapeutics announced in a press release. 

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

A Biologics License Application has been submitted to the FDA for the potential approval of naxitamab for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

An association was found between a lower risk of grade 3 or higher chemotherapy toxicity with higher body mass indexes and normal albumin, a protein made in the liver, levels in older adult patients with solid tumors, according to an analysis of a prospective, multicenter study.

A sudden surge in the cases of COVID-19 due to pandemic, along with efforts to contain it, has led to multiple challenges that no country has experienced in the last several decades. The global pandemic from COVID-19 poses a unique set of challenges not only for patients with cancer who need their treatment, but also for caregivers, oncologists, and the overall care team.

In an interview with&nbsp;Targeted Oncology, Kashyap Patel, MD, discussed the COVID-19 pandemic and the implementation of new precautions in his practice as the number of COVID-19 infected persons rises in the state.<br /> &nbsp;

Patients harboring IDH1/2 muta&shy;tions may receive benefit by the use of PARP inhibitors, with investigators initi&shy;ating clinical trials in patients across multiple different tumor types to determine the efficacy of this strategy.

Treatment with pembrolizumab demonstrated antitumor activity along with tolerable toxicity in patients with 4 different rare and hard-to-treat malignancies, according to results from a phase II study led by The University of Texas MD Anderson Cancer Center researchers and published in the&nbsp;Journal for ImmunoTherapy of Cancer.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

The first chimeric antigen receptor T-cell therapy to utilize chlorotoxin to direct T cells to target cancer cells in the brain has been developed at the City of Hope and demonstrated antitumor activity in a preclinical study. Based on these findings, the first-in-human clinical trial has opened enrollment at City of Hope for patients with recurrent or progressive glioblastoma.

As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.

Patients with aggressive meningiomas presented with clinical and radiological activity when receiving a combination of everolimus&nbsp; and octreotide in the single-arm phase II CEVOREM trial.<br /> &nbsp;