FDA Approves Expanded Indication for Medical Device to Treat Glioblastoma Multiforme

It is indicated in patients with newly-diagnosed glioblastoma multiforme

On 5 October, 2015 the US Food and Drug Administration (FDA) approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include surgery, radiation therapy and chemotherapy used together.

Glioblastoma multiforme accounts for about 15% of all brain tumours, and typically occurs in adults ages 45 to 70. Patients survive less than 15 months on average following diagnosis, because the tumour tends to be highly resistant to standard treatments.

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

Optune was initially approved in 2011 to treat patients with glioblastoma multiforme that recurred or progressed after chemotherapy. With this expanded indication, Optune 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 Optune, a health care professional places electrodes on the surface of the patient’s scalp to deliver low-intensity, alternating electrical fields called tumour treatment fields (TTFields). The unique shape and special characteristics of rapidly dividing tumour cells make them susceptible to damage when exposed to TTFields, which could halt tumour 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 glioblastoma multiforme that compared those who used Optune with temozolomide to those receiving temozolomide alone. Patients who used the device along with temozolomide lived, on average, about seven months with no disease progression compared to four months for those who had the drug alone. The Optune plus temozolomide group survived for an average of 19.4 months after starting treatment compared to 16.6 months for those who were treated with only temozolomide.

Optune for newly diagnosed glioblastoma multiforme was reviewed under the FDA’s priority review programme, 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.

Patients should not use the Optune system if they have an active implanted medical device, a skull defect or 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.