Federal Panel Endorses Cell-Blasting Device to Combat Brain Cancer

A federal advisory panel recommended approval of a device designed to fight brain cancer by using electrical fields to blast the diseased cells.

As The Wall Street Journal reports, the approval comes despite worries that the device, known as the NovoTTF, will not prove effective. The device would be used after conventional remedies fail for glioblastoma, a difficult-to-treat and deadly form of brain cancer.

The Food and Drug Administration advisory panel voted 7-to-3 in favor of approval of the device, with two abstentions. All 12 members of the panel felt that the device was safe, but they divided on whether the trial data demonstrated that it would be effective.

One panelist who abstained, Dr. Sarah Hollingsworth Lisanby of Duke University, told the Journal that while she felt the NovoTTF “could be a real breakthrough,” the clinical trial data submitted by the company were not convincing.

Another panel member, Northwestern University’s Dr. Richard Fessler, who voted in favor of approval, said that the positives outweigh the negatives. He said the device is “clearly better than nothing and these people are at the end of the line.”

Although the panel’s recommendation does not dictate the FDA’s position, the agency typically heeds the outside experts’ advice. A final decision on the NovoTTF is expected in roughly three months.

The trials revolved around 237 glioblastoma patients for whom the standard treatment–commonly a combination of surgery, chemotherapy and radiation–failed. Half were treated with the device, which subjects the brain to alternating electrical fields via electrodes attached to the scalp, while the other half continued with chemotherapy. The device is designed to disrupt the division of brain cancer cells, without harming healthy brain cells that don’t divide.

Patients in each group survived only for a bit more than six months, but there appeared to be slightly better results for those who used the NovoTTF. The company said patients using the device also had a better quality of life, with fewer side effects than typically is the case with new rounds of chemotherapy.

The manufacturer, NovoCure Ltd., said it would work with the FDA  to make sure that the device is used only after other treatments have failed.

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