For your patients with newly diagnosed GBM,

Optune GioTM delivers the power of TTFields to attack GBM cells where they’re vulnerable1

A standard of care proven to provide long-term quality survival without adding systemic toxicity2-4,*

Learn how Optune Gio can selectively destroys cancer cells

*Patient-reported data collected per EORTC QLQ-C30 at baseline and months 3, 6, 9, and 12. The 30-question survey covered 5 daily-functioning domains (Physical, Role, Social, Emotional, and Cognitive).

 

TTFields, Tumor Treating Fields

 

Discover the innovation of Optune Gio

Optune Gio is a wearable treatment delivery system that can provide continuous anti-cancer therapy

What is Optune Gio?

Gill is an Optune Gio user and Patient Ambassador. Patient images reflect the health status of the patient at the time each photo was taken.

Optune Gio leverages biophysical principles to
disrupt tumor viability

Explore how it delivers TTFields, which exert antitumor effects by disrupting activity of cancer cells during multiple phases of mitosis1

In newly diagnosed GBM,

Survival with Optune + TMZ vs TMZ alone was significantly higher at the 2-year landmark analysis and remained higher at 5 years2,5

Among patients with newly diagnosed GBM, more time on Optune Gio resulted in a significantly greater survival benefit7,‡

From a post hoc analysis.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers
include alternating electric fields (Optune Gio) as a Category 1 Preferred regimen, following maximal safe resection if feasible (or else biopsy), and standard radiation therapy with concurrent and adjuvant TMZ, for patients aged ≤70 years with newly diagnosed supratentorial GBM and good performance status regardless of MGMT promoter status.8,§

There is uniform NCCN consensus for this recommendation based on high-level evidence (Category 1), and superior efficacy, safety, evidence, and when appropriate, affordability (Preferred).8

See 5-year analysis published in "JAMA"

§The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial on which the IFU is based used an eligibility criteria of KPS ≥70.2,8

 

National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Submit a prescription, and we take care of the rest

Personalized support from day one, from device training to reimbursement assistance and more

Contact MyNovocure™ to learn more

Find out more about how to start patients on Optune Gio

Integrate Optune Gio into your practice

EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer core quality of life questionnaire; GBM, glioblastoma; KPS, Karnofsky Performance Score; MGMT, O-6-methylguanine-DNA methyltransferase; OS, overall survival; PFS, progression-free survival; TMZ, temozolomide.

References: 1. Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295. 2. Optune. Instructions For Use. Novocure; 2023. 3. Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of treatment with tumor-treating fields and health-related quality of life of patients with newly diagnosed glioblastoma: a secondary analysis of a randomized clinical trial. JAMA. 2018;4(4):495-504. 4. Novocure Data on File US-DOF-0035. 5. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. 6. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multicenter phase III trial of tumor treating fields together with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma. Presented at: 2017 Annual Meeting of the American Association for Cancer Research; April 1-5, 2017; Washington, DC. Oral presentation LBA AACR CT007. 7. Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019;141(2):467-473. 8. Referenced with permission from NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 30, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.

Indications For Use

 

Optune GioTM is intended as a treatment for adult patients (22 years of age or older) with histologically confirmed glioblastoma multiforme (GBM).

 

Optune Gio 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 Gio 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.
 

Important Safety Information

 

Contraindications

Do not use Optune Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.

 

Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.

 

Warnings and precautions

 

Optune Gio can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

 

Do not prescribe Optune Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.

 

The most common (≥10%) adverse events involving Optune Gio in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

 

The most common (≥10%) adverse events seen with Optune Gio monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer.

 

Use of Optune Gio in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune Gio in these patients could lead to tissue damage or lower the chance of Optune Gio being effective.

 

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune Gio treatment.

 

Please click here to see the Optune GioTM Instructions For Use for complete information regarding the device's indications, contraindications, warnings, and precautions.

Novocure Websites

This website is intended for people seeking information on Optune Gio.

On this site, videos and images identified as Optune Gio users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals.

Patient images reflect the health status of the patients at the time each photo or video was taken.

 


External links

Tumortreatingfieldstherapy.com
Optunegio.com
Optunelua.com
Novocuretrials.com


©2023 Novocure GmbH. All Rights Reserved. 

Optune, Optune Gio, MyNovocure, NovoTAL, and Novocure are trademarks of Novocure GmbH. 

All other trademarks, registered or unregistered, are the property of their respective owners. 

US-OPG-00197v1.0 November 2023