WASHINGTON, D.C. April 14, 2011 Novocure today announced that the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100A System (NovoTTF) for the treatment of adult patients with glioblastoma multiforme (GBM) brain tumors, following tumor recurrence after receiving chemotherapy. The portable, wearable device delivers an anti-mitotic, anti-cancer therapy as patients maintain their normal daily activities. The NovoTTF is a novel, first-in-class treatment option for patients and physicians battling glioblastoma.
"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective," said Eilon Kirson, M.D., Ph.D., Novocure's Chief Medical Officer. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients and indirectly on their families."
Results from a 237 patient randomized pivotal trial demonstrated that compared to patients treated with chemotherapy, NovoTTF treated patients achieved comparable median overall survival times, had fewer side effects, and reported improved quality of life scores.
Glioblastoma is the most aggressive and most common form of primary brain tumor in the United States. The disease affects approximately 10,000 Americans each 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 three to four months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.
"We move forward from today proud of the efforts and accomplishments of our team, thankful to our investors for their support and guidance, and humbled by the trust of our patients and physicians." said Asaf Danziger, CEO of Novocure. "Our next task is to make NovoTTF therapy available as a treatment option for al
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Edelman Public Relations