Compliance Management

FDA Gives Nod to Expanded Use of Brain Tumor Device

Oct 06, 2015

The U.S. FDA announced approval of an expanded indication for the Optune device to treat patients with newly diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.
Patients survive less than 15 months on average following diagnosis, because the tumor tends to be highly resistant to standard treatments.

“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “While the treatment is not a cure, it can increase survival by several months.”

Optune was initially approved in 2011 to treat patients with GBM that recurred or progressed after chemotherapy. With this expanded indication, Optune can be used as part of a standard treatment for GBM before the disease progresses.

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