Novocure Ltd. has obtained US Food and Drug Administration (FDA) approval for its non-invasive NovoTTF-100A System for the treatment of brain tumors. The NovoTTF is the first ever medical device for the treatment of cancer as an alternative to chemotherapy.
The NovoTTF device was approved for treatments of adults whose glioblastoma multiforme (GBM) brain tumors recurred after chemotherapy. The portable, wearable device delivers an anti-mitotic, anti-cancer therapy as patients maintain their normal daily activities.
The FDA approval was based on results of a Phase III clinical trial of 237 patients with recurring brain tumors found that the NovoTTF achieved comparable medial survival period compared patients treated with chemotherapy. The device also caused fewer side effects and patients reported improved quality of life.
Novocure chief medical officer Dr. Eilon Kirson said, "Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective. The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients."
Novocure is conducting clinical trials of the NovoTTF on newly diagnosed brain tumors and on lung cancer, both in combination with chemotherapy.
Glioblastoma is the most aggressive and most common form of primary brain tumor in the US, affecting 10,000 people a year. The median overall survival time from initial diagnosis is 15 months with optimal therapy, and median survival from the time of tumor recurrence is only 3-4 months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.
Novocure CEO Asaf Danziger said, "Our next task is to make NovoTTF therapy available as a treatment option for all recurrent GBM patients in the US."
Novocure chairman William Doyle added, "We look forward to developing NovoTTF therapy for a range of additional solid tumor cancers."
Novocure is headquartered in Jersey in the Channel Islands and has a research center in Haifa, and US offices in Portsmouth, New Hampshire.
Published by Globes [online], Israel business news - www.globes-online.com - on April 17, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011