The U.S. Food and Drug Administration (FDA) approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive and deadly form of adult brain cancer. This medical device is used along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.
When using Optune, the neurosurgeon places electrodes on the surface of the patient’s scalp to deliver low-intensity, alternating electrical fields called “tumor treatment fields” (TTFields). The unique shape and special characteristics of rapidly dividing tumor cells make them susceptible to damage when exposed to TTFields, which could halt tumor growth.
"This is such wonderful news and a great milestone in the treatment of glioblastoma," said Dr. Ayguen Sahin, MSc, PhD, a brain cancer scientist, Founder and CEO of Cancer Research Simplified, a Boston-based, global cancer education nonprofit. "Glioblastoma multiforme or GBM is the most common, aggressive and deadly type of brain cancer in adults and it is highly resistant to therapies. It is great that this device can now be used as part of a standard treatment along with temozolomide, rather then being used as an adjunct therapy strategy."
Optune was initially approved in 2011 to treat patients with GBM that recurred or progressed after chemotherapy. With this expanded indication, Optune can be used as part of a standard treatment for GBM before the disease progresses.
The FDA's approval is based on results from a clinical trial involving 695 patients newly diagnosed with GBM that compared those who used Optune with TMZ to those receiving TMZ alone.
Optune device + TMZ = patients lived, on average, about seven months with no disease progression
TMZ alone = patients lived, four months
Optune device + TMZ = patients survived for an average of 19.4 months after diagnosis
TMZ = 16.6 months
Learn more about Optune: http://www.optune.com/HCP/therapy.aspx
Frequently Asked Questions (FAQ) about Optune: http://www.optune.com/resources/questions.aspx/