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FDA advisors back oncology device

Advisors to the US FDA have voted in favour of Novocure's noninvasive medical device designed to slow tumour growth
Advisors to the US Food and Drug Administration (FDA) have voted in favour of a noninvasive medical device being developed by a small oncology company called Novocure and is designed to slow tumor growth.

The Neurological Devices Advisory Panel of the FDA's Medical Devices Advisory Committee voted seven to three, with two abstentions, that for patients with supra-tentorial glioblastoma multiforme (GBM) tumours that recur after maximal surgical and radiation treatments, the benefits of the company's NovoTTF-100A System (NovoTTF) outweigh its risks when administered as a monotherapy in place of chemotherapy.  

The small, portable device creates a low-intensity electric field inside the tumour throughout the day intended to prevent the mitotic process through which cancer cells divide and replicate.

The FDA advisors voted after reviewing final data from a phase III trial of 237 patients with glioblastoma tumours that had recurred or progressed despite previous treatments. The study showed that patients treated with the NovoTTF alone had similar overall survival time to those treated with chemotherapy and also had higher rates of progression-free survival at six months and higher tumor response rates compared to the chemotherapy-treated patients.

In addition, the NovoTTF patients reported better quality of life and fewer side effects than those administered chemotherapy, with the most common device-related side effect being a mild-to-moderate rash under the electrodes.

Novocure is currently conducting a phase III study comparing use of the device plus Merck's Temodar (temozolomide) to Temodar alone, which is the current best standard of care. The study will enroll 283 patients with newly diagnosed glioblastoma at 26 centres in the US, Europe, and Israel.  

The device has already been awarded the CE Mark and is available to patients in Europe.

18th March 2011

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