©2020 Novocure. All rights reserved.
Dr. James M. Chimenti and Dr. Richard V. Buonocore are now certified to prescribe Optune® for the treatment of newly diagnosed and recurrent glioblastoma (GBM). This wearable and portable medical device is the first FDA-approved treatment in more than a decade for newly diagnosed GBM.
Optune is approved for the treatment of adult patients (22 years of age or older) with GBM. For recurrent patients, it can be used alone when surgery and radiation treatment options have been exhausted. For newly diagnosed patients, Optune is used with the chemotherapy temozolomide (TMZ) after surgery and radiation with TMZ. A large clinical trial of patients with newly diagnosed GBM showed that adding Optune to TMZ provided a greater opportunity to live longer compared to TMZ alone at 5 years (13% vs 5%). People in the study were also able to maintain their mental, emotional, and physical well-being longer than those on chemotherapy alone.
Optune creates low-intensity alternating electric fields–called Tumor Treating Fields (TTFields)–which potentially slow or stop cell division leading to cell death. Because TTFields do not enter the bloodstream like a drug, they did not significantly increase TMZ-related side effects for newly diagnosed patients. In clinical trials the most common device related adverse events when using Optune alone were scalp irritation from device use and headache. You can learn more about this treatment here: Optune.com.
©2020 Novocure. All rights reserved. Optune, Optune Lua, nCompass, NovoTAL, and Novocure are trademarks of Novocure. All other trademarks, registered or unregistered, are the property of their respective owners. US-OPT-03765 October 2020. https://www.optune.com/how-optune-works, accessed January 13, 2021.
Indications for Use
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.
Important Safety Information
Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective. Do not use the NovoTTF-100L System in patients with MPM with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc.
Use of Optune for GBM or the NovoTTF-100L System for MPM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Do not use Optune for GBM or the NovoTTF-100L System for MPM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune and the NovoTTF-100L System may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.
©2019 Novocure. All rights reserved. Optune and Novocure are trademarks of Novocure. Document number: QSD-QR-703. Revision 02. Issue Date: January 2019. Instructions for Use. https://www.optune.com/Content/pdfs/Optune_IFU_8.5×11.pdf. Accessed January 13, 2021.