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The FDA has granted approval of the Optune device, made by Novocure, for adjuvant use in the treatment of newly diagnosed glioblastoma (GBM). The device consists of electrode arrays placed on the scalp and attached to a portable battery pack. The arrays transmit low-intensity, intermediate-frequency, alternating electrical fields across the tumor. In laboratory testing, this type of alternating electrical field disrupts the process of mitosis and cell division, which in the brain is believed to occur mainly in tumor cells and not healthy cells.
A pivotal international, randomized, open-label phase III study was undertaken in patients with newly diagnosed GBM who had undergone maximal surgical resection followed by combined radiation and dail…