FDA panel: Novocure's brain tumor device improves quality of life but not survival rate
March 16, 2011 by MassDevice staff
The FDA's neurological devices panel says NovoCure's portable, continuous electronic brain tumor treatment may improve cancer patients' quality of life, but doesn't "show a statistically significant difference" in overall survival rate when measured against chemotherapy.
A revolutionary treatment for a deadly form of brain cancer failed to show a significant increase in the overall survivability rate when measured against chemotherapy, according to an FDA reviewers document posted on the agency's web site.
In reviewer materials released ahead of a March 17 meeting of the FDA's neurological devices panel, Food & Drug Administration officials questioned claims made by NovoCure, a privately-held Israeli company, which is seeking pre-market approval for its NovoTTF-100A device.
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