The U.S. Food and Drug Administration has approved an expanded indication for the Optune device for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM), to be given in combination with temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.
Optune (also known as Tumor Treating Fields or TTFields) is a therapy delivered by a portable, non-invasive medical device designed for continuous use by patients that creates low-intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
"Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available," William Maisel, MD, MPH, Acting Director of the FDA's Office of Device Evaluation in the Center for Devices and Radiological Health, said in a news release. "While the treatment is not a cure, it can increase survival by several months."
Optune, made by NovoCure, was initially approved in 2011 (then called the NovoTTF-100A System or NovoTTF) to treat patients with GBM that recurred or progressed after chemotherapy (OT 5/10/11 issue). With this expanded indication, Optune can be used as part of a standard treatment for GBM before the disease progresses. Optune had received Priority Review designation for this indication earlier this year (OT 6/25/15 issue).
Approximately 23,000 individuals in the U.S. will be diagnosed with brain or other nervous system cancers in 2015, with GBM accounting for approximately 15 percent of them, according to data from the National Cancer Institute.
How It Works
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.
Safety and Efficacy
Approval for the Optune device was based on data from a randomized, Phase III clinical trial of 695 patients with newly diagnosed GBM who either used the Optune device and received TMZ or received TMZ alone. Patients receiving TMZ and using the Optune device had a median overall survival of 20.5 months, while patients receiving TMZ alone had a median overall survival of 15.6 months.
Side Effects
The most common side effect reported by patients using the Optune device was skin irritation. And patients on the clinical trial who used the Optune device also had a slightly higher incidence of neurological side effects, including convulsions and headaches, compared with subjects receiving TMZ alone.
Clinical Quick Facts: Optune
Device: Optune
Approved Indication: Treatment for newly diagnosed glioblastoma multiforme, to be given in combination with temozolomide following standard treatments that include surgery, chemotherapy, and radiation therapy.
Common Side Effects: Skin irritation
[[Patients on the clinical trial who used the Optune device also had a slightly higher incidence of neurological side effects, including convulsions and headaches]]