The US Food and Drug Administration announced an expanded indication for the Optune device to treat newly diagnosed patients with glioblastoma multiforme.
The US Food and Drug Administration (FDA) announced an expanded indication for a device to treat patients with glioblastoma multiforme (GBM). The Optune device (Novocure Inc), which uses electric fields to slow tumor growth, was already approved for the treatment of GBM that recurred or progressed after treatment with chemotherapy, and is now approved for newly diagnosed patients as well.
“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health, in a press release.
GBM accounts for about 15% of all brain tumors, and offers generally poor prognosis. The Optune device is a noninvasive technology involving the placement of electrodes on the head in order to deliver “tumor treatment fields,” alternative electrical fields that can damage tumor cells and slow the tumor’s growth. It is designed to be worn continuously, and is now indicated to be used in newly diagnosed GBM in concert with standard chemotherapy with temozolomide.
The new approval is based on positive interim results from the EF-14 trial, which were presented in November 2014. In that report, 315 patients were randomized to either the Optune device (called NovoTTF at the time) and temozolomide or temozolomide alone.
The median progression-free survival was 7.1 months with the device and 4.0 months without, for a hazard ratio (HR) of 0.63 (P = .001). The overall survival was also better, at 19.6 months vs 16.6 months, for an HR of 0.75 (P = .034). The 24-month survival rate was 43% with Optune and 29% without it. Adverse events were similar between the groups; the primary adverse event related to Optune was skin irritation.
Because the trial met its primary and secondary endpoints, accrual was stopped early, and the authors concluded that the device should become the new standard of care. Since then, data from the rest of the patients who had already joined the trial have been reported, and results remain similar. According to the FDA, the average overall survival among 695 patients in the EF-14 trial was 19.4 months with Optune, compared with 16.6 months for chemotherapy alone.
The FDA’s expanded approval followed a priority review of the device, which grants a quicker process toward approval than is standard.