FDA Approves Novocure’s HFE Transducer Arrays for Optune Gio® in Glioblastoma

Novocure (NASDAQ: NVCR) has announced that the U.S. Food and Drug Administration (FDA) has approved its new Head Flexible Electrode (HFE) transducer arrays for use with the Optune Gio® device, which is used to treat adult patients with glioblastoma multiforme (GBM).

Optune Gio is a portable, wearable device that generates alternating electric fields, known as Tumor Treating Fields (TTFields). These fields are administered through non-invasive, wearable arrays and work by exerting physical forces on the electrically charged components of dividing cancer cells, thereby disrupting their rapid division.

The newly approved HFE arrays have a flexible polymer material replacing the ceramic discs used in the current Optune Gio arrays. This innovation makes the arrays one-third lighter and 50% thinner. Mukund Paravasthu, Chief Operating Officer at Novocure, emphasized that the new arrays are designed to be more comfortable for patients, while maintaining efficacy. He highlighted the company's commitment to delivering product innovations that prioritize patient needs.

Novocure plans to transition Optune Gio users in the U.S. to the new HFE arrays through the first half of 2025, following a controlled transition plan.

Optune Gio is a wearable, portable device approved by the FDA for treating glioblastoma multiforme (GBM) in adult patients aged 22 or older. For newly diagnosed GBM, Optune Gio is used in conjunction with temozolomide (TMZ) chemotherapy, provided the cancer is confirmed by a healthcare professional and surgery has been performed to remove as much of the tumor as possible. For recurrent GBM, Optune Gio can be used alone if previous surgeries, radiation, and chemotherapy have failed or are no longer effective.

Patients with certain medical conditions should avoid using Optune Gio. These include those with an implanted medical device, a skull defect, or a bullet fragment, as the device has not been tested in these circumstances. Additionally, individuals with a known sensitivity to conductive hydrogels should not use the device. Pregnant women or those planning to become pregnant should also avoid using Optune Gio, as its safety and effectiveness during pregnancy are not established.

Before using Optune Gio, patients should receive proper training from qualified medical personnel. They should use only the parts provided in the Optune Gio Treatment Kit and avoid getting the device or transducer arrays wet. Patients with serious scalp skin conditions should discuss their suitability for Optune Gio treatment with their doctor.

The most common side effects of using Optune Gio with chemotherapy include low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation, headache, seizures, and depression. When used alone, the most common side effects are scalp irritation and headaches. Other side effects may include malaise, muscle twitching, falls, and skin ulcers. Patients should consult their doctor if they experience any of these side effects or have concerns.

Tumor Treating Fields (TTFields) are electric fields that apply physical forces to kill cancer cells through various mechanisms. These fields do not significantly impact healthy cells due to their different properties. TTFields therapy can be integrated with other cancer treatments, such as chemotherapy, radiotherapy, immune checkpoint inhibitors, or targeted therapies, to enhance their effects across various solid tumor types.

Novocure is a global oncology company focused on extending survival in aggressive cancers through its innovative TTFields therapy. Approved products are available in several countries for treating glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. Novocure continues to explore TTFields therapy in clinical trials for other cancers, including pancreatic cancer. The company has its global headquarters in Root, Switzerland, with U.S. headquarters in Portsmouth, New Hampshire, and research and development facilities in Haifa, Israel.