On November 21, 2024 Novocure (NASDAQ: NVCR) reported that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio for the treatment of adult patients with glioblastoma multiforme (GBM) (Press release, NovoCure, NOV 21, 2024, View Source [SID1234648567]).

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"At Novocure we recognize product innovation must deliver meaningful results for our patients"

Optune Gio is a wearable, portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, which disrupt the rapid cell division exhibited by cancer cells.

The new HFE arrays utilize a flexible polymer material in place of the ceramic discs used in the current Optune Gio arrays, making them one-third lighter and 50% thinner.

"At Novocure we recognize product innovation must deliver meaningful results for our patients," said Mukund Paravasthu, Chief Operating Officer, 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."

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

Important Safety Information

What is Optune Gio approved to treat?

Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.

Newly diagnosed GBM

If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if:

Your cancer is confirmed by your healthcare professional AND
You have had surgery to remove as much of the tumor as possible
Recurrent GBM

If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if:

You have tried surgery and radiation and they did not work or are no longer working AND
You have tried chemotherapy and your GBM has been confirmed by your healthcare professional
Who should not use Optune Gio?

Optune Gio is not for everyone. Talk to your doctor if you have:

An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly
A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction
Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.

What should I know before using Optune Gio?

Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure, the maker of Optune Gio.

Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor
Do not get the device or transducer arrays wet
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment
What are the possible side effects of Optune Gio?

Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.

Please click here for the Optune Gio Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.