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National Brain Tumor Society Statement on FDA Approval of Optune for Treatment of Glioblastoma Patients

2015-10-06

National Brain Tumor Society (NBTS) interim Chief Executive Officer David Arons issued the following statement on the U.S. Food and Drug Administration’s (FDA) approval yesterday of Novocure’s Optune, a medical device to treat newly diagnosed glioblastoma multiforme (GBM) patients in combination with the chemotherapy temozolomide (brand name: Temodar) following standard treatment of surgery and radiation therapy. Optune, previously called NovoTTF-100A, had originally received FDA approval to treat recurrent GBM patients in 2011:

“For patients diagnosed with glioblastoma, treatment options have been limited with no new advances in recent years. As such, NBTS is pleased by the FDA’s decision to approve Optune based on necessary clinical safety and efficacy data. The approval of this device gives GBM patients another much needed option when considering a treatment regime that is right for them.

NBTS is hopeful that the FDA’s approval of this device influences others in the field to increase investment in this therapeutic area. Optune reveals a path to approval for this orphan indication and 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 tumor patients.

NBTS is also looking forward to continuing discussions with leaders in the field about the implications of this latest approval for brain tumor patients as well as brain tumor R&D by biopharmaceutical companies. Importantly, we also call upon health insurers to take action to provide adequate coverage of Optune in both the newly-diagnosed and recurrent settings. The cost of a new treatment should not be a barrier to care.”

According to its announcement, the FDA based its approval of the expanded indication of the Optune device on results from a large phase 3 clinical trial conducted across a number medical centers in the U.S., as well as Europe, South Korea, and Israel. The trial compared newly diagnosed GBM patients using Optune with temozolomide to those receiving temozolomide alone, following surgery and radiation. In the study, patients treated with the device and temozolomide lived a median of three months longer than those treated with the chemotherapy alone.

Optune is a portable battery or power-supply operated device, which produces changing electrical fields, called tumor treatment fields (“TTFields”) intended to disrupt the growth of tumor cells. Patients wear a backpack containing the device’s battery and electrodes directly on their scalp. Optune is meant to be used continuously.

  • Dawn Isis

    My sister had this treatment or something very much like it – but it didn’t help. Perhaps it was already too late. Why they didn’t start her on it asap after her second tumor-removal surgery I will never know. The tumors had already started growing again by the time they got her on it, over six weeks after the surgery. She lost the ability to walk six weeks after that, and stopped the electrode treatment. She died about 10 weeks after that. The second anniversary of her passing is tomorrow, Oct. 11.
    What about the polio virus injections they are using at Duke University? Seems a lot more promising!!

    -Dawn Isis, Campbell, CA – re Beverly Isis, 30-year resident of Inwood at the northern tip of Manhattan; 1955 – 2013.

    • TomHalkinNBTS

      Hi Dawn – Thank you for reading and sorry to hear about the loss of your sister. It saddens us to hear stories of loss, but it also contributes to our resolve and determination to keep fighting in the memory and honor of Beverly and all the others we’ve lost to this terrible disease. We are committed to finding better treatments and ultimately a cure!

      As far as the poliovirus work at Duke, we are certainly encouraged by the results they have shared to date, and look forward to seeing this potential treatment progress. We helped provide funding to the work that led to the discovery of the poliovirus – you can read a bit more here: http://blog.braintumor.org/60-minutes-joins-the-fight-against-brain-tumors/

  • Juliana Morais dos Santos

    Hello, I’m from Brazil my nephew has 2 tumors . How can he get the Optune?

    • TomHalkinNBTS

      Hi Juliana – Sorry to hear about your nephew. NBTS is an American organization, and are only familiar with medical policy and regulation. I suggest checking with the International Brain Tumor Alliance (IBTA), they will likely have better information (or contacts) that can help with your questions. Best of luck.

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