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Roger Stupp, MD, discusses final results of a randomized, multi-center, phase III trial investigating tumor treating fields added to standard chemotherapy in newly diagnosed glioblastoma.

The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.

Hideho Okada, MD, PhD, director, Brain Tumor Immunotherapy Center, professor of Neurological Surgery, University of California, San Francisco, discusses a study exploring vaccination in patients with glioblastoma.

Several agents are being investigated for the treatment of patients with glioblastoma in an ongoing phase II clinical trial. Known as the INdividualized Screening Trial of Innovative Glioblastoma Therapy, the study will randomize patients to 1 of 4 arms—either the control arm of standard-of-care agent temozolomide, or 1 of 3 experimental arms.

The novel oncolytic virus Toca 511 (vocimagene amiretrorepvec) and Toca FC (extended-release 5-fluorocytosine [5-FC]) induced durable responses in patients with recurrent glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), for a median duration of response of 35.1+ months, according to findings from a phase I study presented during the 2017 AACRNCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In a pooled analysis of 3 phase I studies, the virus also proved to be well tolerated with fewer any-grade adverse events (AEs) than with standard chemotherapy.1

Disease-free survival is maintained in women with postmenopausal hormone receptor-positive breast cancer treated with aromatase inhibitors, even when the treatment is only given for 2 years in comparison with the standard 5 years of additional aromatase inhibitor therapy, according to findings from the phase III ABCSG-16 trial presented at the 2017 San Antonio Breast Cancer Symposium.

After previously receiving an accelerated approval, bevacizumab (Avastin) has been granted a full approval by the FDA for the treatment of adult patients with glioblastoma that progressed following prior therapy, according to Genentech, the manufacturer of the VEGF inhibitor.

Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

The authors share their experience with EGFRvIII-specific chimeric antigen receptors, which they hope will contribute to the growing body of research committed to discovering a novel therapy for glioblastoma.

In a 17-0 vote, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab.

NewYork-Presbyterian has established the William Rhodes and Louise Tilzer-Rhodes Center for Glioblastoma, to be led by physicians from Columbia University Medical Center and Weill Cornell Medicine.

Hideho Okada, MD, PhD, director, Brain Tumor Immunotherapy Center, professor of Neurological Surgery, University of California, San Francisco, discusses a study exploring vaccination in low-grade glioma aiming at prevention of high-grade transformation.

The American Association for Cancer Research has announced Michael A. Caligiuri, MD, will serve as its president and Elizabeth M. Jaffee, MD, will serve as its president-elect for the 2017-2018 term.

Mutations in isocitrate dehydrogenase 1 and 2 (<em>IDH1/2</em>) are not the mutations commonly found in cancer cells, according to a presentation from the 2017 AACR Annual Meeting.

A landmark analysis of findings from the EF-14 trial testing the efficacy and safety of tumor treating fields for the treatment of patients with glioblastoma multiforme has found that the risk of death was reduced by 37% and overall survival was extended by a median of 5 months with the use of the device.

Evanthia Galanis, MD, discusses the issues that currently exist in clinical trial design in oncology and neuro-oncology, as well as how they can be addressed.

Antonio Iavarone, MD, professor of Pathology and Cell Biology and Neurology, Columbia University, Institute for Cancer Genetics, discusses the role of the ID2 protein in patients with malignant brain tumors.

Genetic counselor Krista Qualmann, MS, CGC, discusses the syndromes she is identifying in patients in her clinic, as well as how they could impact brain tumor treatment.

The use of tumor treating fields as a treatment for patients with brain tumors has, thus far, largely been focused on in glioblastoma, but an upcoming trial aims to expand the use of the device to the grade III patient population, says Daniel O’Connell, MD.

Arie Perry, MD, chief of neuropathology at UCSF in San Francisco, California, discusses what oncologists should be aware of when diagnosing patients after these reclassifications, how it could change pathology, as well as a discussion on hereditary tumors.

In an interview with <em>Targeted Oncology</em>, Howard Fine discusses the reason for renewed interested in metabolic targets, the effect it has had on treatment of gliomas, and what he sees on the horizon for neuro-oncology in this area.<br />

Evanthia Galanis, MD, professor of oncology, Mayo Clinic, discusses how to best optimize clinical trial design in brain cancer and other cancer types.

Treatment with onartuzumab did not provide any additional clinical benefit when added to bevacizumab (Avastin) in the treatment of patients with recurrent glioblastoma multiforme (GBM), according to a study recently published in the <em>Journal of Clinical Oncology</em>.

Howard Fine, MD, director, Brain Tumor Center, Weill Cornell Medicine, discusses the history of metabolic targets in brain cancer.

Entrectinib Will Likely Play an Increasing Role in Treating Brain Tumors, Other Cancers, Expert Says
Researchers are currently investigating the use of tropomyosin receptor kinase (TRK) inhibitor entrectinib (RXDX-101) to treat patients with relapsed or refractory solid tumors or primary tumors of the central nervous system.































