FDA Approves Life-Extending Device for Newly Diagnosed Glioblastoma
The U.S. Food and Drug Administration on Monday expanded its approval for the Optune device to include newly diagnosed glioblastoma multiforme.
HealthDay News -- The U.S. Food and Drug Administration on Monday expanded its approval for the Optune device to include newly diagnosed glioblastoma multiforme.
Optune involves placing electrodes on the surface of the scalp to deliver low-intensity pulses called tumor treatment fields, which are designed to damage growing tumor cells, the agency said in a news release. The portable device, powered by battery or plugged into a common electric outlet, can be used at home or work.
Optune was first approved in 2011 to treat this type of brain cancer once it had progressed despite chemotherapy. It's been newly sanctioned to treat just-diagnosed patients, in combination with temozolomide. Clinical studies of the device for this purpose showed people treated with the Optune/drug combination lived an average of three months longer than those treated with the drug alone.
Skin irritation is the most common side effect, and users also have a slightly greater-than-average risk of neurologic adverse reactions, including convulsions or headaches, the FDA said. People with an implanted medical device, skull abnormality, or skin sensitivity should not use Optune, the agency said.
The device is manufactured by Portsmouth, N.H.-based Novocure Inc.