Company broadens geographic reach of Optune in community
setting, making therapy more accessible to patients
Internationally, GBM patients can access Optune at an additional
350 medical institutions
Novocure™ (NASDAQ: NVCR) announced today that physicians at more
than 600 cancer treatment centers in the U.S. have been certified
to prescribe Optune to newly diagnosed and recurrent glioblastoma
(GBM) patients. Optune is Novocure’s wearable, portable,
FDA-approved Tumor Treating Fields (TTFields) delivery system for
the treatment of GBM. Physicians at an additional 350 medical
institutions throughout the world also can prescribe Optune to GBM
patients.
“We are proud to have certified physicians at a variety of
cancer treatment centers, both large and small, in the community
and academic settings, nationally and worldwide,” said Novocure’s
CEO Asaf Danzinger. “It is our goal to bring our therapy to all GBM
patients who can benefit from it. Optune is now more accessible to
GBM patients than ever before, and we remain focused on broadening
its reach.”
The latest physician certifications broaden the geographic reach
of Optune in the community setting, making the therapy more
accessible to patients.
“As a pioneer of community-based oncology, we strive to enhance
patient access to innovative cancer treatments so patients can stay
connected to the support of their families, friends and community
during the challenging time of a cancer diagnosis,” said Dr. Joseph
C. Hodges, a radiation oncologist and certified Optune prescriber
at Texas Oncology in Longview, Texas. “Optune provides immense
benefit to GBM patients, and we are excited to now offer this
treatment to our patients.”
About Novocure
Novocure is an oncology company developing a profoundly
different cancer treatment utilizing a proprietary therapy called
TTFields, the use of electric fields tuned to specific frequencies
to disrupt solid tumor cancer cell division. Novocure’s
commercialized product, Optune, is approved for the treatment of
adult patients with glioblastoma. Novocure has ongoing or completed
clinical trials investigating TTFields in brain metastases,
non-small cell lung cancer, pancreatic cancer, ovarian cancer and
mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in
Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York
City. Additionally, the company has offices in Germany,
Switzerland, Japan and Israel. For additional information about the
company, please visit www.novocure.com or follow us at
www.twitter.com/novocure.
Approved Indications
In the United States, Optune is intended as a treatment for
adult patients (22 years of age or older) with
histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for
the treatment of adult patients with newly diagnosed,
supratentorial glioblastoma following maximal debulking surgery and
completion of radiation therapy together with concomitant standard
of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune
is indicated following histologically-or radiologically-confirmed
recurrence in the supratentorial region of the brain after
receiving chemotherapy. The device is intended to be used as a
monotherapy, and is intended as an alternative to standard medical
therapy for GBM after surgical and radiation options have been
exhausted.
In the European Union, Optune is intended for the treatment of
patients with newly diagnosed GBM, after surgery and radiotherapy
with adjuvant temozolomide, concomitant to maintenance
temozolomide. The treatment is intended for adult patients, 18
years of age or older, and should be started more than 4 weeks
after surgery and radiation therapy with adjuvant temozolomide.
Treatment may be given together with maintenance temozolomide and
after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment
of patients with recurrent GBM who have progressed after surgery,
radiotherapy and temozolomide treatment for their primary disease.
The treatment is intended for adult patients, 18 years of age or
older, and should be started more than 4 weeks after the latest
surgery, radiation therapy or chemotherapy.
In Japan, Optune (NovoTTF-100A) is approved in the treatment of
adult patients with supra-tentorial glioblastoma (GBM) and is used
following maximal safe surgical resection and radiation
therapy.
Patients should only use Optune under the supervision of a
physician properly trained in use of the device. Full prescribing
information is available at www.optune.com/safety or by
calling toll free 1-855-281-9301 in the US or by email
at supportEMEA@novocure.com in the European Union.
Important Safety Information
Contraindications: Do not use Optune if you have an
active implanted medical device, a skull defect (such as, missing
bone with no replacement), or bullet fragments. Use of Optune
together with implanted electronic devices has not been tested and
may theoretically lead to malfunctioning of the implanted device.
Use of Optune together with skull defects or bullet fragments has
not been tested and may possibly lead to tissue damage or render
Optune ineffective.
Do not use Optune if you are known to be sensitive to conductive
hydrogels. In this case, skin contact with the gel used with Optune
may commonly cause increased redness and itching, and rarely may
even lead to severe allergic reactions such as shock and
respiratory failure.
Warnings and Precautions: Use Optune only after receiving
training from qualified personnel, such as your doctor, a nurse, or
other medical personnel who have completed a training course given
by Novocure (the device manufacturer).
Do not use Optune if you are pregnant, you think you might be
pregnant or are trying to get pregnant. It is not known if Optune
is safe or effective in these populations.
The most common (≥10%) adverse events involving Optune in
combination with temozolomide were low blood platelet count,
nausea, constipation, vomiting, fatigue, scalp irritation from
device use, headache, convulsions, and depression.
The most common (≥10%) adverse events seen when using Optune
alone were scalp irritation from device use and headache.
The following adverse reactions were considered related to
Optune when using the device alone: scalp irritation from device
use, headache, malaise, muscle twitching, fall and skin ulcer.
All servicing procedures must be performed by qualified and
trained personnel.
Do not use any parts that do not come with the Optune Treatment
Kit, or that were not sent to you by the device manufacturer or
given to you by your doctor.
Do not wet the device or transducer arrays.
If you have an underlying serious skin condition on the scalp,
discuss with your doctor whether this may prevent or temporarily
interfere with Optune treatment.
Please see http://www.optune.com/safety to see the
Optune Instructions For Use (IFU) for complete information
regarding the device’s indications, contraindications, warnings,
and precautions.
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, development of potential products,
interpretation of clinical results, prospects for regulatory
approval, manufacturing development and capabilities, market
prospects for its products, 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 “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, regulatory and political
conditions as well as more specific risks and uncertainties facing
Novocure such as those set forth in its Annual Report on Form 10-K
filed on February 23, 2017, 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: http://www.businesswire.com/news/home/20170712005605/en/
NovocureMedia and Investor Contact:Ashley
Cordova212-767-7558acordova@novocure.com
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