Novocure has obtained FDA clearance for its next-generation head flexible electrode (HFE) transducer arrays designed for use with Optune Gio, a wearable device indicated for treating adults with glioblastoma. The updated wearable aims to improve patient comfort during treatment.
The new HFEs have been modified to be lighter and thinner, addressing comfort concerns reported by patients using the device for extended periods. Novocure intends to transition existing Optune Gio users in the United States to the new HFE arrays throughout the first half of 2025, implementing a carefully managed transition plan.
Optune Gio works by fitting onto a patient's scalp and emitting alternating electric fields, referred to by the company as Tumor Treating Fields (TTFields). These TTFields are designed to be used in conjunction with temozolomide (TMZ) chemotherapy and exert physical forces on electrically charged components within dividing cancer cells, thereby inhibiting further tumor growth.
The mechanism of action involves disrupting the rapid division characteristic of cancer cells. By applying alternating electric fields, Optune Gio interferes with the mitotic spindle formation and chromosome segregation during cell division, ultimately leading to cell cycle arrest and apoptosis.
This approval follows the recent FDA clearance of another Novocure TTField-emitting wearable, Optune Lua, which is indicated for use alongside PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic non-small cell lung cancer (mNSCLC). The parallel approvals underscore Novocure's commitment to expanding the application of TTFields therapy across different cancer types.
"At Novocure, we recognize product innovation must deliver meaningful results for our patients," said Mukund Paravasthu, Novocure’s chief operating officer. "The newly FDA-approved HFE arrays are lighter, thinner, and designed to be more comfortable, and have clear benefits for the patient. We look forward to introducing the new arrays in the US and will continue our work to deliver product innovations that prioritize the needs of people using our treatments."
Novocure currently has 29 products in active stages of development. In Q3 2024, the company reported revenues of $155 million, reflecting a 22% year-over-year increase. As of the latest financial report, 4,113 patients are actively using Novocure’s TTFields therapy, with over half of these users located in the United States.
