The American Food and Drug Administration (FDA) has just approved Optune, a portable, battery-powered medical device to be used in conjunction with the chemotherapy drug temozolomide (Temodar) for the treatment of glioblastoma multiforme (GBM) patients.
Optune, manufactured by Novocure, is classed as a Tumour Treating Fields delivery system; a non-invasive device that delivers changing electrical fields designing to disrupt tumour cell growth. It is powered by a portable battery pack with electrodes sitting directly on the scalp.
The approval follows large phase 3 clinical trials across the U.S., Europe, South Korea and Israel. The trials focused on patients using the combination of Optune with temozolomide and temozolomide alone with significant results.
“For patients diagnosed with glioblastoma, treatment options have been limited with no new advances in recent years," says David Arons, CEO of the National Brain Tumour Society in America (NBTS).
“NBTS is hopeful that the FDA's approval of this device influences others in the field to increase investment in this therapeutic area.
“NBTS is encouraged that further research and development will produce treatments that continue to make strides in the extension of survival and enhancement of quality of life for all brain tumour patients."