FDA Expands Indication for Optune Device for Newly Diagnosed Glioblastoma
The FDA has approved expanded indication for the Optune device to treat patients with newly diagnosed glioblastoma multiforme.
The U.S. Food and Drug Administration (FDA) has approved an expanded indication for the Optune device to treat patients with newly diagnosed glioblastoma multiforme (GBM) to be given along with temozolomide following standard treatment, including surgery, chemotherapy, and radiotherapy.1
“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” said William Maisel, MD, MPH, 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 by the FDA for the treatment of patients with recurrent GBM or disease that progressed after chemotherapy. Now, Optune can be used along with standard treatment prior to disease progression.
Optune is a portable device that delivers low-intensity, alternating electrical fields called “tumor treatment fields” to the patient's scalp via electrodes placed on the surface.
In regard to safety, the most common side effect is skin irritation. Participants in the clinical trial also experienced a slightly higher incidence of neurological adverse events, including convulsions and headaches, compared with those who received temozolomide alone.
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The approval of the expanded indication is based on a clinical trial that compared Optune with temozolomide with temozolomide alone in 695 patients with newly diagnosed glioblastoma. The device improved both progression-free survival and overall survival vs chemotherapy alone.
- FDA approves expanded indication for medical device to treat a form of brain cancer [news release]. Silver Spring, MD: U.S. Food and Drug Administration; October 5, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465744.htm. Accessed October 7, 2015.