The FDA announced approval of the NovoTTF-100A System for the treatment
of adult patients with glioblastoma multiforme brain tumors, following tumor
recurrence and treatment with chemotherapy. The six-pound, portable, wearable
device delivers an anti-mitotic, anti-cancer therapy.
“Recurrent glioblastoma multiforme is a devastating form of brain
cancer that often eludes standard treatments,” Jeffrey Shuren, MD,
JD, director of the FDA’s Center for Devices and Radiological Health,
said in a press release. “The agency’s approval of the NovoTTF-100A
System shows FDA’s commitment to innovative new devices that provide
patients with other treatment options.”
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Jeffrey Shuren
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In March, the FDA Neurological Devices Advisory Panel of the Medical
Devices Advisory Committee
voted
7 to 3 in favor of the device. Approval is based on results of a phase 3
trial that demonstrated comparable OS rates between patients treated with the
NovoTTF-100A System (NovoCure) and those who underwent chemotherapy.
The device was also associated with improved quality of life compared
with chemotherapy, according to a survey of patients in the study.
Patients should not use the NovoTTF-100A System if they have an
implanted medical device or a skull defect, or have a known sensitivity to
conductive hydrogels, such as those used with electrocardiograms, the FDA wrote
in the release. The NovoTTF-100A System is not intended to be used in
combination with other cancer treatment; the device should only be used after
other treatments have failed.