The U.S. Food and Drug Administration has 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.
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