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April 18, 2011

FDA Approves Device to Treat Glioblastoma Multiforme

The US Food and Drug Administration (FDA) has approved the NovoTTF-100A System, a portable device to treat adults with glioblastoma multiforme that recurs or progresses after chemotherapy and radiation therapy. While using the device, the NovoTTF-100A System, healthcare personnel place

By cms admin

The US Food and Drug Administration (FDA) has approved the NovoTTF-100A System, a portable device to treat adults with glioblastoma multiforme that recurs or progresses after chemotherapy and radiation therapy.

While using the device, the NovoTTF-100A System, healthcare personnel place electrodes on the patient’s scalp to deliver low-intensity, varying electrical fields called tumour treatment fields to the tumour site.

The division of tumour cells make them susceptible to damage when exposed to tumour treatment fields, stopping tumour growth.

The Novocure-developed device can be charged with batteries or plugged into an electrical outlet, and can be used by patients at home.

The FDA’s approval was based on results from a single international clinical study involving 237 patients with recurrent glioblastoma multiforme or with glioblastoma multiforme that hadn’t responded to traditional therapy.

The study showed the NovoTTF-100A System exhibited comparable overall survival rates to those who underwent chemotherapy.

The patients treated with the NovoTTF-100A System showed higher incidence of neurological side effects such as convulsions and headaches compared to patients receiving chemotherapy, but they did not experience other side effects associated with chemotherapy, including nausea, anaemia, fatigue and serious infections.

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