Optune Lua for MPM is classified as a Humanitarian Use Device (HUD), approved under the Humanitarian Device Exemption (HDE) pathway
An HUD is a medical device intended to benefit patients with a disease or condition that affects fewer 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)
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 per year
MPM, malignant pleural mesothelioma.
References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2019. 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. 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 Humanitarian Device Exemption (HDE) Program: Draft Guidance for Industry and Food and Drug Administration Staff.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. 4. 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. 5. Hazarika M, White RM, Johnson JR, Pazdur R. FDA drug approval summaries: pemetrexed (Alimta®). The Oncologist. 2004;9(5):482-488. 6. 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.