The Food and Drug Administration has approved a portable, battery-powered device that delivers electrical fields to the brain as a treatment for adults with glioblastoma multiforme that has recurred after chemotherapy, the manufacturer and agency announced on April 15.
The approval of the NovoTTF-100A System (NovoTTF), manufactured by Israel-based Novocure, was based on the results of a randomized company-sponsored study of 237 patients with glioblastoma multiforme (GBM) that had recurred or progressed after surgical, radiation, and chemotherapy treatments.
Photo credit: Novocure
The NovoTTF-100A is a portable, battery-powered device that delivers electrical fields to the brain as a treatment for glioblastoma multiforme.
In the study, overall survival rates were "comparable," between patients treated with the device and those given best available chemotherapy, according to the FDA. Median overall survival had been reported as 6.3 months and 6.4 months, respectively.
The agency cited evidence suggesting that quality of life improved among those treated with the device, compared with those on chemotherapy. While the incidence of convulsions, headaches, and other neurologic side effects were slightly increased among those treated with the device, they did not experience chemotherapy-related side effects, the agency noted.
The device, which weighs about 6 pounds, is intended to be worn about 20 hours per day. It can run on batteries or be plugged into an electric outlet.
When using the device, the device’s electrodes are placed on the patient’s scalp, "to deliver low-intensity, changing electrical fields called "tumor treatment fields" (TTFs) to the tumor site," the FDA statement said: "The unique shape and electrical characteristics of dividing tumor cells make them susceptible to damage when exposed to TTF, which could stop tumor growth."
The most common treatment-associated adverse event reported was mild to moderate rash under the electrodes. The FDA said it should not be used in patients who "have an implanted medical device or a skull defect, or have a known sensitivity to conductive hydrogels, such as those used with electrocardiograms."
The company press release characterized the device as an alternative to chemotherapy, but the agency announcement stressed that it should not be used with other treatments. Rather the agency said "the device should only be used after other treatments have failed."
At a meeting in March, the majority of the FDA’s Neurological Devices Advisory Panel voted that the benefits of treatment with the device exceeded its risks when used as monotherapy in adults who have exhausted surgical and radiation treatment options for histologically or radiologically confirmed recurrent GBM.
Although the study was designed as a superiority study and failed to show treatment with the device was superior to chemotherapy, panelists said that because of its safety profile and evidence of benefit in some patients, they supported approval.
Novocure is conducting a study of the device in patients with newly diagnosed GBM tumors.
The device has been approved in the European Union as a treatment for newly diagnosed and recurrent GBM and for the treatment of non–small cell lung cancer.