FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme
The U.S. Food and Drug Administration (FDA) has approved an expanded indication for the Optune tumor-treating fields device to treat patients with newly diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include surgery, chemotherapy, and radiation therapy.
In the clinical study used to support the expanded indication, patients treated with the device and temozolomide lived on average 3 months longer than those treated with temozolomide alone.
Optune was initially approved in 2011 to treat patients with glioblastoma multiforme that recurred or progressed after chemotherapy. With this expanded indication, the device can be used as part of a standard treatment for glioblastoma multiforme before the disease progresses.
For newly diagnosed glioblastoma multiforme, 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 the device, a health-care professional places electrodes on the surface of the patient’s scalp to deliver low-intensity, alternating electrical fields called tumor-treating fields. The unique shape and special characteristics of rapidly dividing tumor cells make them susceptible to damage when exposed to tumor-treating fields, 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.
Clinical Trial Results
The FDA based its approval of the expanded indication of the device on results from a clinical trial involving 695 patients newly diagnosed with glioblastoma multiforme that compared those who used Optune with temozolomide with those receiving temozolomide alone. Patients who used the device along with temozolomide lived, on average, about 7 months with no disease progression compared with 4 months for those who had the drug alone. The Optune-plus-temozolomide group survived for an average of 19.4 months after diagnosis compared with 16.6 months for those who were treated with temozolomide alone.
Optune for newly diagnosed glioblastoma multiforme 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 the device was skin irritation. Clinical trial participants also experienced a slightly higher incidence of neurologic side effects. ■