Treatment for glioblastoma (GBM)
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Optune® Novocure™
What does unprecedented really mean?

For newly diagnosed GBM,

Proven superior long-term survival with Optune + TMZ vs TMZ alone with 5 years of clinical evidence1

Median OS was significantly extended—by nearly 5 months (P<0.001)1

Optune + TMZ also significantly improved PFS vs TMZ alone1

Median: 6.7 months vs 4.0 months (P<0.001)

Optune + TMZ has demonstrated consistent superiority vs TMZ alone in all analyses since the interim results were reported1

  • Median OS: 20.5 months vs 15.6 months (P=0.004)3
  • Median PFS: 7.2 months vs 4.0 months (P=0.001)3

For 5 consecutive years, Optune + TMZ consistently sustained superior rates of survival1,2

Optune + TMZ significantly extended median OS Optune + TMZ significantly extended median OS Optune + TMZ significantly extended median OS Optune + TMZ significantly extended median OS Optune + TMZ significantly extended median OS

As seen by the P values, the improvement demonstrated by Optune + TMZ was highly significant year after year

In the 5-year survival analysis, Optune + TMZ also demonstrated consistently superior OS across all patient subgroups analyzed, regardless of their1:

MGMT
methylation status
Extent of
resection
Age
Performance status
Gender

CI, confidence interval, HR, hazard ratio; ITT, intent to treat; OS, overall survival; PFS, progression-free survival; TMZ, temozolomide.

References: 1. 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. 2. Stupp R, Idbaih A, Steinberg DM, et al. Prospective, multi-center 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. 3. Optune Instructions For Use. Novocure 2016. 4. Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trial. JAMA. 2015;314(23):2­5­3­5­-­2­5­4­3. 5. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;3­5­2:9­8­7­-­9­9­6.

5-year results published in JAMA

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OPT-055.2-11


*The NCCN defines good performance as Karnofsky Performance Score (KPS) ≥60. The trial for which the IFU is based used an eligibility criteria of KPS ≥70.
The NCCN 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.

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.

Important Safety Information

Contraindications

Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. 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 Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune 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 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 for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

The most common (10%) adverse events involving Optune 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 monotherapy were medical device site reaction and headache.

The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer.

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

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


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

On this site, patient and healthcare professional videos as well as all images labeled as Optune users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals. All other depictions of patients and caregivers are actor portrayals.

Indications For Use

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