Portable glioblastoma treatment device receives approval

The FDA has approved a portable therapeutic system that can be used at home by adults who have glioblastoma multiforme (GBM) that has recurred or progressed following chemotherapy and radiotherapy.

GBM—the most common primary brain cancer—is highly resistant to such standard treatments as surgery, radiation, and chemotherapy. The newly approved NovoTTF-100A System (Novocure, Portsmouth, New Hampshire) delivers low-intensity, changing electrical fields known as tumor treatment fields (TTF) to the tumor site. The dividing tumor cells have unique shapes and electrical characteristics that make them susceptible to damage resulting from TTF exposure. This damage could stop tumor growth.

The electrical fields are delivered through electrodes placed on the patient's scalp by a health care professional. The patient can use the device at home. The system can run on batteries or can be plugged into an electrical outlet, enabling the person to proceed with normal daily activities.

In an international clinical study of 23 persons suffering from recurrent GBM or GBM that had not responded to therapy, patients treated with the NovoTTF system had comparable overall survival rates to those undergoing chemotherapy, but did not experience the significant side effects associated with chemotherapy (nausea, anemia, fatigue, and serious infections). The NovoTTF users did, however, experience a slightly higher incidence of neurologic side effects—convulsions and headaches—compared with the chemotherapy group (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm251669.htm).  

The device should only be used after other treatments have failed. It is not intended for use in combination with other cancer treatments, nor should it be used by persons with an implanted medical device, a skull defect, or a known sensitivity to conductive hydrogels.

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