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FDA Approval

Optune Lua for MPM is classified as a Humanitarian Use Device (HUD), approved under the Humanitarian Device Exemption (HDE) pathway^1-3

An HUD is a medical device intended to benefit patients with a disease or condition that affects no more than 8,000 individuals in the United States per year.³

The HDE pathway was implemented by the FDA to encourage:

Companies to innovate in rare diseases with underserved patient populations

Once approved by the FDA through the HDE pathway, use of the HUD in a facility is overseen by an appropriate Local Committee (LC) or the Institutional Review Board (IRB)

IRB Resource Kit

This kit provides you with useful materials to help get your patients started with Optune Lua treatment. The kit includes:

HCP and patient resources
The required materials you will need for an IRB submission

Download here

An HDE may be granted if³:

The device will not expose patients to an unreasonable or significant risk of illness or injury, and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use while taking into account the probable risks and benefits of currently available devices or alternative forms of treatment

The device would not be available to a person with the disease or condition in question without the HDE

The device is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States annually

See overall survival results

Next: What is Optune Lua?

MPM, malignant pleural mesothelioma.

References: 1 Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2021. 2. Ceresoli GL, Aerts JG, Dziadziuszko R, et al. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019;20(12):1702-1709. doi:10.1016/S1470-2045(19)30532-7 3. US FDA. Humanitarian Device Exemption (HDE) Program: Draft Guidance for Industry and Food and Drug Administration Staff. September 6, 2019. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389275.pdf. Accessed January 3, 2020.

Important Safety Information

Contraindications

Do not use Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of Optune Lua together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Optune Lua 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 Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of Optune Lua 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 device site reaction and skin breakdown/skin ulcer.

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

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

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