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FDA Expands Optune's Glioblastoma Multiforme Indication

Silas Inman @silasinman
Published: Monday, Oct 05, 2015

William Maisel, MD

William Maisel, MD, MPH

The FDA has approved Optune (formally the NovoTTF-100A System) in combination with adjuvant temozolomide as a treatment for patients with newly diagnosed glioblastoma multiforme (GBM) following surgery, chemotherapy, and radiation therapy, based on an improvement in survival in the EF-14 trial.

“These results are spectacular,” lead investigator Roger Stupp, MD, director of the University Hospital Cancer Center at the University of Zurich, Zurich, Switzerland, said in a statement when the findings were presented. “A new standard of care for patients suffering from glioblastoma is born.”

Clinical trials continue to assess Optune in various combinations for patients with brain cancer, including a phase II study exploring the treatment in combination with bevacizumab and temozolomide for unresectable GBM (NCT02343549). Additionally, a clinical trial is exploring Optune as a treatment for patients with small cell lung cancer with central nervous system metastasis (NCT02425072). The therapy is also being explored in earlier settings in combination with bevacizumab and hypofractionated stereotactic irradiation in bevacizumab-naive patients with recurrent GBM (NCT01925573).

Stupp R, Wong E, Scott C, et al. Interim analysis of the EF-14 trial: a prospective, multicenter trial of NovoTTF-100A together with temozolomide compared to temozolomide alone in patients with newly diagnosed GBM. Presented at: 19th Annual Meeting of the Society for Neuro-Oncology; November 13-16, 2014: Miami, FL.

 

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Community Practice Connections™: Overcoming Clinical Inertia in Glioblastoma Multiforme: The Experts Weigh-In on Recent Data Sets and Next Steps to Move the Field ForwardDec 21, 20191.5
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