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Brain-cancer device now FDA-approved

April 18, 2011|By Marissa Cevallos, HealthKey

Brain tumors may soon encounter a new weapon. The Food and Drug Administration has approved a new device that uses electrical energy to kill brain cancer cells. The device, approved for those who have malignant tumors known as glioblastoma multiforme, adds a potential new alternative to chemotherapy for patients with advanced brain tumors.

The device, called NovoTTF, delivers low-intensity electrical fields directly to a patient’s scalp via four electrodes. The electrical fields appear to interfere with the process of cell division, halting the tumor’s growth.

In a clinical trial of 237 patients with glioblastoma, the most common and aggressive form of brain cancer, those who wore the device lived as long as patients who received chemotherapy—about six months. But the device-wearers didn’t have the debilitating side effects of nausea, fatigue, anemia and serious infection common to chemotherapy. 

The device-wearers did have more neurological side effects, including convulsions and headaches, compared with those who underwent chemotherapy. Actually wearing the device could be a headache too—the 6-pound device is carried in a satchel, day and night, while four electrodes warm the (shaved) areas of the scalp. Still, a survey of the two groups suggested that those who wore the device had a better quality of life than those who received chemotherapy.

The device is only intended more or less as a last try—surgery, chemotherapy, and radiation therapy are the standard ways of trying to slow down brain cancer -- but for patients with recurring cancers the options are slim.

And it’s a novel approach, especially of note considering that the FDA is under fire for approving some medical devices on a fast-track, bypassing the standard guidelines for testing. Such an approval process is designed for products similar to ones already on the market.

The brain device, however, wasn’t approved on the fast-track because it’s different from brain-cancer treatments already available. Very different. 

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