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FDA Approves the NovoTTF-100A System for the Treatment of Patients With Recurrent Glioblastoma Multiforme (GBM) Brain Tumors

April 15, 2011 By Bio-Medicine.Org

WASHINGTON, April 15, 2011 /PRNewswire/ — 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.  

(Photo:  http://photos.prnewswire.com/prnh/20110415/CG83483-a)

(Photo:  http://photos.prnewswire.com/prnh/20110415/CG83483-b)

“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

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SOURCE

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