Optune Lua for MPM is classified as a Humanitarian Use Device (HUD), approved under the Humanitarian Device Exemption (HDE) pathway1
An HUD is a medical device intended to benefit patients with a disease or condition that affects less than 8,000 individuals in the United States per year. The marketing approval process for an HUD is the HDE pathway.2
The HDE pathway was created to encourage2:
Companies to innovate in rare diseases with underserved patient populations.
Use of this pathway by permitting HDE eligible devices to be approved without conducting traditional large scale clinical trials.
Once approved by 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 if2:
The device will not expose patients to an unreasonable or significant risk of illness or injury
The probable benefit to health from use of the device outweighs the risk of injury or illness from its use
No comparable device is available
Optune Lua is the first FDA-approved MPM treatment in over 15 years1,3-5
References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2019. 2. US FDA. Humanitarian Device Exemption (HDE) Program: Draft Guidance for Industry and Food and Drug Administration Staff. June 2018. https://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM389275.pdf. Accessed August 6, 2019. 3. 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. 4. Hazarika M, White RM, Johnson JR, et al. FDA drug approval summaries: pemetrexed (Alimta®). The Oncologist. 2004;9(5):482-488. 5. 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.