Washington, DC - The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.

Nearly 23,000 Americans will be diagnosed with brain or other nervous system cancers in 2015, according to the National Cancer Institute, and more than 15,000 will die from them. GBM accounts for about 15 percent of all brain tumors, and typically occurs in adults ages 45 to 70. Patients survive less than 15 months on average following diagnosis, because the tumor tends to be highly resistant to standard treatments.

“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “While the treatment is not a cure, it can increase survival by several months.”

In the clinical study used to support the expanded indication, patients treated with the device and TMZ lived on average three months longer than those treated with the drug alone.

Optune was initially approved in 2011 to treat patients with GBM that recurred or progressed after chemotherapy. With this expanded indication, Optune can be used as part of a standard treatment for GBM before the disease progresses.

For newly diagnosed GBM, Optune is not intended to be used as a substitute for standard treatments, but rather as an adjunct therapy, and should not be used without a physician’s supervision.

When using Optune, a health care professional places electrodes on the surface of the patient’s scalp to deliver low-intensity, alternating electrical fields called “tumor treatment fields” (TTFields). The unique shape and special characteristics of rapidly dividing tumor cells make them susceptible to damage when exposed to TTFields, which could halt tumor growth. 

The device is portable and can be powered with batteries or plugged into an electrical outlet. Patients can use the device at home or work, allowing them to continue their normal daily activities. 

The FDA based its approval of the expanded indication of the Optune device on results from a clinical trial involving 695 patients newly diagnosed with GBM that compared those who used Optune with TMZ to those receiving TMZ alone. Patients who used the device along with TMZ lived, on average, about seven months with no disease progression compared to four months for those who had the drug alone. The Optune plus TMZ group survived for an average of 19.4 months after diagnosis compared to 16.6 months for those who were treated with only TMZ. 

Optune for newly diagnosed GBM 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 side effect experienced with Optune was skin irritation. Clinical trial participants also experienced a slightly higher incidence of neurological side effects, including convulsions and headaches, compared to subjects receiving TMZ alone.

Patients should not use the Optune system if they have an active implanted medical device or a skull defect, have an underlying skin condition involving the scalp or have a known sensitivity to conductive hydrogels, such as those used on electrocardiogram stickers.

The Optune System is made by Novocure Inc. of Portsmouth, New Hampshire.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.