FDA News

FDA approves Optune for newly diagnosed glioblastoma multiforme

The FDA expanded the approval of the Optune device to treat patients with newly diagnosed glioblastoma multiforme in combination with temozolomide.

Optune (Novocure) is a portable device that delivers tumor treating fields — or low-intensity, alternating electrical fields — through electrodes placed on the surface of the patient’s scalp. Rapidly dividing tumor cells may be susceptible to damage when exposed to tumor treating fields, thus halting tumor growth.

The FDA based its decision in part on results of a trial that included 695 patients with newly diagnosed glioblastoma multiforme (GBM) assigned to receive temozolomide chemotherapy alone or with Optune. Patients who received Optune achieved longer PFS (about 7 months vs. 4 months) and OS (19.4 months vs. 16.6 months).

The most common side effect associated with Optune is skin irritation. More patients treated with Optune on the clinical trial also experienced neurological side effects, such as convulsions and headaches.

The FDA approved Optune in 2011 for the treatment of patients with GBM that recurred or progressed after chemotherapy.

“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” William Maisel, MD, MPH, acting director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release. “While the treatment is not a cure, it can increase survival by several months.”

The FDA expanded the approval of the Optune device to treat patients with newly diagnosed glioblastoma multiforme in combination with temozolomide.

Optune (Novocure) is a portable device that delivers tumor treating fields — or low-intensity, alternating electrical fields — through electrodes placed on the surface of the patient’s scalp. Rapidly dividing tumor cells may be susceptible to damage when exposed to tumor treating fields, thus halting tumor growth.

The FDA based its decision in part on results of a trial that included 695 patients with newly diagnosed glioblastoma multiforme (GBM) assigned to receive temozolomide chemotherapy alone or with Optune. Patients who received Optune achieved longer PFS (about 7 months vs. 4 months) and OS (19.4 months vs. 16.6 months).

The most common side effect associated with Optune is skin irritation. More patients treated with Optune on the clinical trial also experienced neurological side effects, such as convulsions and headaches.

The FDA approved Optune in 2011 for the treatment of patients with GBM that recurred or progressed after chemotherapy.

“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” William Maisel, MD, MPH, acting director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release. “While the treatment is not a cure, it can increase survival by several months.”