Novocure’s HFE Transducer Arrays OK’ed with Optune Gio for Glioblastoma

Novocure has gained U.S. Food and Drug Administration (FDA) approval of its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio to treat adult patients with glioblastoma multiforme (GBM).

Optune Gio is a wearable, portable device that produces Tumor Treating Fields (TTFields) that are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells. This disrupts cancer cells’ rapid cell division.

The HFE arrays use a flexible polymer material instead of the ceramic discs used in the current Optune Gio arrays. This renders them one-third lighter and half as thin, according Novocure.

The company said it plans to convert U.S. Optune Gio users to the new HFE arrays through H1 2025 through a controlled transition plan.

“At Novocure we recognize product innovation must deliver meaningful results for our patients,” said Mukund Paravasthu, chief operating officer of Novocure. “The newly FDA approved HFE arrays are lighter, thinner and designed to be more comfortable, clear benefits for the patient. We look forward to introducing the new arrays in the U.S. and will continue our work to deliver product innovations that prioritize the needs of people using our treatments.”

Last month, Novocure received FDA approval of its Optune Luna for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, to treat adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen.