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Optune is the first MHLW-approved therapy in more than a decade to demonstrate statistically and clinically significant extension of survival in newly diagnosed GBM patients
ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ:NVCR) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved second generation Optune. Second generation Optune features a Tumor Treating Fields (TTFields) generator that is less than half the weight and half the size of the first generation generator, weighing less than 1.3 kilograms (2.7 pounds). The smaller, lighter TTFields delivery system is now available to glioblastoma (GBM) patients in all of Novocure's active markets.
"The MHLW's approval of second generation Optune represents another important milestone for Novocure in Japan as we prepare for a broad commercial launch pending reimbursement approval," said Shungo Matori, Novocure's General Manager, Japan and Representative Director of Novocure K.K. "We are dedicated to making Optune available to GBM patients who can benefit from our therapy. This approval enables us to provide Japanese patients with the latest TTFields technology, designed to be make it even easier for patients to incorporate treatment with Optune into their lives."
Novocure established commercial operations in Japan in March 2015 after the MLHW approved Optune for the treatment of recurrent GBM. In December 2016, the MLHW approved Optune for the treatment of newly diagnosed GBM and Novocure is currently preparing to submit an application for public reimbursement of Optune. Approximately 1,500 people are diagnosed with GBM or tumors that typically progress to GBM in Japan each year.
The MHLW's approval of Optune for the treatment of newly diagnosed GBM was supported by Novocure's phase 3 pivotal EF-14 trial results, which showed significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone. Optune is the first MHLW-approved therapy in more than a decade to demonstrate statistically and clinically significant extension of survival in newly diagnosed GBM.
Novocure is an oncology company developing a profoundly different cancer treatment centered on 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 built a commercial organization and launched Optune for the treatment of GBM in the United States, Germany, Switzerland and Japan, referred to as Novocure's currently active markets. 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 and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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.
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.
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.
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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