New flexible arrays are lighter, thinner and
designed to improve comfort for Optune Gio users
Novocure (NASDAQ: NVCR) announced today 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).
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.
To learn more about TTFields therapy and its multifaceted effect
on cancer cells, visit tumortreatingfields.com.
About Novocure
Novocure is a global oncology company working to extend survival
in some of the most aggressive forms of cancer through the
development and commercialization of its innovative therapy, Tumor
Treating Fields. Novocure’s commercialized products are approved in
certain countries for the treatment of adult patients with
glioblastoma, non-small cell lung cancer, malignant pleural
mesothelioma and pleural mesothelioma. Novocure has several
additional ongoing or completed clinical trials exploring the use
of Tumor Treating Fields therapy in the treatment of glioblastoma,
non-small cell lung cancer and pancreatic cancer.
Novocure’s global headquarters is located in Root Switzerland,
with U.S. headquarters located in Portsmouth, New Hampshire and
research and development facilities located in Haifa, Israel. For
additional information about the company, please visit Novocure.com
and follow @Novocure on LinkedIn and X (Twitter).
Forward-Looking Statements
In addition to historical facts or statements of current
condition, this press release may contain forward-looking
statements. Forward-looking statements provide Novocure’s current
expectations or forecasts of future events. These may include
statements regarding anticipated scientific progress on its
research programs, clinical study progress, development of
potential products, interpretation of clinical results, prospects
for regulatory approval, manufacturing development and
capabilities, market prospects for its products, coverage,
collections from third-party payers and other statements regarding
matters that are not historical facts. You may identify some of
these forward-looking statements by the use of words in the
statements such as “could” “anticipate,” “estimate,” “expect,”
“project,” “intend,” “plan,” “believe” or other words and terms of
similar meaning. Novocure’s performance and financial results could
differ materially from those reflected in these forward-looking
statements due to general financial, economic, environmental,
regulatory and political conditions and other more specific risks
and uncertainties facing Novocure such as those set forth in its
Annual Report on Form 10-K filed on February 22, 2024, and
subsequent filings with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of
these forward-looking statements may prove to be incorrect.
Therefore, you should not rely on any such factors or
forward-looking statements. Furthermore, Novocure does not intend
to update publicly any forward-looking statement, except as
required by law. Any forward-looking statements herein speak only
as of the date hereof. The Private Securities Litigation Reform Act
of 1995 permits this discussion.
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version on businesswire.com: https://www.businesswire.com/news/home/20241121353761/en/
Investors: Ingrid Goldberg investorinfo@novocure.com
Media: Catherine Falcetti media@novocure.com
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