The US Food and Drug Administration (FDA) has expanded the indication for the Optune device (Novocure), which will allow it to be used to treat patients with newly diagnosed glioblastoma multiforme.
Optune, also known as the NovoTTF-100A System was initially approved in 2011 to treat patients with glioblastoma multiforme that had recurred or progressed after treatment.
The new indication will allow the device to be used in conjunction with standard treatment (chemotherapy with temozolomide; Temodar, Merck) in the first-line setting.
"Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in a statement. "While the treatment is not a cure, it can increase survival by several months."
Optune is a novel and noninvasive regional therapy that targets dividing cancer cells in the brain and generally does not harm healthy tissue. It delivers low-intensity, intermediate-frequency, alternating electric fields called tumor treating fields. Electrodes are placed directly on the scalp to target the tumor, and array placement is determined based on each patient's individual magnetic resonance imaging results to maximize the therapy's effect on the tumor.
The expanded indication for Optune is based on the results of EF-14, a large, multinational, open-label, randomized phase 3 trial comparing Optune in combination with temozolomide with temozolomide alone in 700 patients with newly diagnosed glioblastoma multiforme. An interim analysis showed that use of the device improved overall survival by about 3 months.
Patients who used the device combined with temozolomide had a median overall survival of 19.4 months compared with 16.6 months for those who were treated with only chemotherapy, the FDA noted. The company added in a press release that the results from the "as-treated population" show that median overall survival was 20.5 months compared with 15.6 months (hazard ratio, 0.66; P = .004). Median progression-free survival was 7.2 months compared with 4.0 months (hazard ratio, 0.62; P = .001).
Elizabeth Wilson, president and chief executive officer of the American Brain Tumor Association, Chicago, Illinois, commented in a statement: "For a disease for which there are few treatment options, Optune offers new hope for extending survival from the start of treatment."
Optune is portable and can be powered both with batteries or plugged into an electrical outlet, which allows patients the freedom to resume their normal daily activities while undergoing treatment.
The FDA cautions that Optune is not intended as a substitute for standard treatments in newly diagnosed patients but, rather, as an adjunct therapy.
The expanded indication was reviewed under the FDA's priority review program, which provides for an expedited review of certain devices that treat life-threatening conditions.
The most common adverse effect experienced with Optune was skin irritation, and participants in the clinical trial also reported experienced a slightly higher incidence of neurological adverse effects, including headaches, compared with those who received temozolomide alone.
The use of Optune is contraindicated in patients who have an active implanted medical device or a skull defect, an underlying skin condition involving the scalp, or have a known sensitivity to conductive hydrogels, such as those used on electrocardiogram stickers.
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Cite this: FDA Expands Indication for Optune Device in Glioblastoma - Medscape - Oct 06, 2015.