Optune was approved to be used in conjunction with the chemotherapy drug temozolomide (Temodar) for the treatment of glioblastoma multiforme (GBM) patients. It is powered by a portable battery pack with electrodes sitting directly on the scalp.
The approval follows large phase three 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."