NovoTTF-100L™ logo
NovoTTF-100L™ logo

For the first time in over 15 years, there's a new treatment for mesothelioma

The NovoTTF-100L System is now FDA approved to treat mesothelioma*

NovoTTF-100L is intended to be used concurrently with pemetrexed + cisplatin/carboplatin
  • NovoTTF-100L is used together with chemotherapy
  • NovoTTF-100L allows you to get continuous treatment almost anywhere while going about your daily activities
*Unresectable, locally advanced or metastatic, malignant pleural mesothelioma.
The NovoTTF-100L system is wearable and portable

The NovoTTF-100L System is wearable and portable

More than 10,000 patients globally have started a cancer treatment that works the same way as NovoTTF-100L. It is called Optune, and has been used since 2011 to treat a tumor called glioblastoma.

More than 10,000 patients globally have started a cancer treatment that works the same way as NovoTTF-100L. It is called Optune and has been used since 2011 to treat a tumor called glioblastoma.

NEW for MPM

Announcing the first FDA-approved treatment
for mesothelioma in over 15 years1-4

The NovoTTF-100L System is now FDA approved for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM)1,2

NovoTTF-100L is intended to be used concurrently with pemetrexed + cisplatin/carboplatin NovoTTF-100L is intended to be used concurrently with pemetrexed + cisplatin/carboplatin

NovoTTF-100L is intended to be used concurrently with pemetrexed + cisplatin/carboplatin.1

NovoTTF-100L for MPM is classified as a Humanitarian Use Device (HUD), approved under the Humanitarian Device Exemption (HDE)1

More than 10,000 patients have started Optune—a treatment for glioblastoma (GBM) with the same mechanism of action as NovoTTF-100L1,5,6

FDA approved since 2015 for newly diagnosed GBM7

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial GBM following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy

FDA approved since 2011 for recurrent GBM7

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

Optune was approved under the Premarket Authorization (PMA) pathway.8

nCompass logo

Complete support
every step of the way
Novocure partners with your patients at every step of their treatment journey

From the first question about NovoTTF-100L and throughout your treatment, the nCompass team at Novocure provides customized support based on your individual needs.

From the first question about NovoTTF-100L and throughout your patients' treatment, the nCompass team at Novocure provides customized support based on their individual needs.

24-hour support from nCompass

Call us toll free,
any time of day:
1-855-281-9301

References: 1. NovoTTF-100L Instructions For Use for Unresectable Malignant Pleural Mesothelioma. Novocure 2019. 2. FDA Approves the NovoTTF-100L™ System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma [press release]. St. Helier, Jersey: Business Wire; May 23, 2019. 3. Hazarika M, White RM, Johnson JR, et al. FDA drug approval summaries: pemetrexed (Alimta®). The Oncologist. 2004;9(5):482-488. 4. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003;21(14):2636-2644. 5. Novocure Corporate presentation. https://www.novocure.com/wp-content/uploads/2019/01/201901_NVCR_Corporate_Presentation_vF-1.pdf. Published January 2019. Accessed April 16, 2019. 6. Optune Instructions For Use. Novocure 2019. 7. Summary of Safety and Effectiveness Data (SSED). US FDA Website. https://www.accessdata.fda.gov/cdrh_docs/pdf10/p100034s013b.pdf. Accessed April 9, 2019. 8. US Food and Drug Administration. Premarket Approval (PMA) Database. Silver Spring, MD: US Department of Health and Human Services; 2015. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100034S013. Updated May 13, 2019. Accessed May 16, 2019.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

What is the NovoTTF-100L System approved to treat?

The NovoTTF-100L System is a wearable, portable, FDA-approved device indicated for the treatment of adult patients, with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used together with standard chemotherapy (pemetrexed and platinum-based chemotherapy).

What is Optune approved to treat?

Optune is indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.

Newly diagnosed GBM

If you have newly diagnosed GBM, Optune is used together with a chemotherapy called temozolomide (TMZ) if:

  • Your cancer is confirmed by your healthcare professional AND
  • You have had surgery to remove as much of the tumor as possible

Recurrent GBM

If your tumor has come back, Optune can be used alone as an alternative to standard medical therapy if:

  • You have tried surgery and radiation and they did not work or are no longer working AND
  • You have tried chemotherapy and your GBM has been confirmed by your healthcare professional

Who should not use the NovoTTF-100L System for MPM or Optune for GBM?

The NovoTTF-100L System for MPM and Optune for GBM are not for everyone. Talk to your doctor if you have:

  • MPM and an implanted electronic medical device including a pacemaker, implantable automatic defibrillator, etc. The NovoTTF-100L System has not been tested in people with implanted electronic devices, which may cause the devices not to work properly
  • GBM and an implanted medical device (programmable shunt), skull defect (missing bone with no replacement) or bullet fragment. Optune has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune has not been tested in people with skull defects or bullet fragments, which may cause Optune not to work properly.
  • A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp or upper body like the ones used on EKGs). When the NovoTTF-100L System/Optune comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction

Do not use the NovoTTF-100L System for MPM or Optune for GBM if you are pregnant or are planning to become pregnant. It is not known if the NovoTTF-100L System/Optune is safe or effective during pregnancy.

What should I know before using the NovoTTF-100L System for MPM or Optune for GBM?

The NovoTTF-100L System and Optune should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of the NovoTTF-100L System and Optune.

  • Do not use any parts that did not come with the NovoTTF-100L System or Optune Treatment Kit sent to you by Novocure or given to you by your doctor.
  • Do not get the device or transducer arrays wet
  • Please be aware that the NovoTTF-100L System and Optune have a cord that may cause tripping when connected to an electric socket
  • If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with the NovoTTF-100L System or Optune treatment

What are the possible side effects of the NovoTTF-100L System for MPM and Optune for GBM?

The most common side effects of the NovoTTF-100L System when used together with chemotherapy for MPM (pemetrexed and platinum-based chemotherapy) were low red blood cell count, constipation, nausea, tiredness, chest pain, fatigue, skin irritation from device use, itchy skin, and cough.

Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin irritation, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical site reaction and skin breakdown/skin ulcer.

The most common side effects of Optune when used together with chemotherapy for GBM (temozolomide or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression.

The most common side effects when using Optune alone for GBM were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers.

Talk to your doctor if you have any of these side effects or questions


Please click here to see the NovoTTF-100L Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.


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

Indications For Use

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.

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 the NovoTTF-100L System in patients with MPM with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. 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.

Use of the NovoTTF-100L System for MPM or Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use the NovoTTF-100L System for MPM or Optune for GBM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with the NovoTTF-100L System and Optune may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

The NovoTTF-100L System and Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure®.

The most common (10%) adverse events involving the NovoTTF-100L System in combination with chemotherapy in patients with MPM were anemia, constipation, nausea, asthenia, chest pain, fatigue, device skin reaction, pruritus, and cough.

Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical site reaction and skin breakdown/skin ulcer.

The most common (10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.

The most common (10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with the NovoTTF-100L System and Optune treatment.

Do not prescribe the NovoTTF-100L System or Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of NovoTTF-100L System and Optune in these populations have not been established.


Please click here to see the NovoTTF-100L Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.


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

What is the NovoTTF-100L System
approved to treat?

The NovoTTF-100L System is a wearable, portable, FDA-approved device indicated for the treatment of adult patients, with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used together with standard chemotherapy (pemetrexed and platinum-based chemotherapy).

Indications For Use

The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.