Novocure Converts More Than 500 U.S. Patients to Second Generation Optune within Four Weeks of FDA Approval on July 13
The second generation device is less than half the weight and half the size of the first generation Optune System
ST. HELIER, Jersey–(BUSINESS WIRE)–Before starting treatment with Optune in October 2015, Michael Olson, 39, of Beaumont, Texas, worried about how he’d incorporate the treatment into his life and practice as a dentist. It wasn’t long before he started feeling comfortable with the device, and he says half of his patients don’t notice he is wearing it.
Mr. Olson, a father of two, was able to continue working full time and continue doing the things he enjoyed while receiving treatment with the first generation Optune System. However, he recently received the second generation Optune System, which is less than half the weight and size of the first generation Optune System. He says he can carry the device comfortably while treating patients and the batteries are easier to change. He further enjoys not having to stop treatment to change batteries or power source with the device’s “No-Stop Swap” feature.
The new features of the second generation Optune System also have helped Mr. Olson when traveling with his family. This summer, the Olsons spent eight days in Yellowstone National Park. Mr. Olson said that, based on his recent experience, he expects managing the device while traveling will be easier, which he believes will help with his treatment compliance. For their next vacation, the Olsons plan to visit Hawaii.
“I can absolutely incorporate Optune into my daily life,” said Mr. Olson, who has aimed to maintain as much of a normal routine as possible since his diagnosis.
Mr. Olson is one of the more than 500 U.S. patients to convert to Novocure’s second generation Optune System in the four weeks since the U.S. FDA approved the new device on July 13, 2016. Including its battery, the second generation Optune System weighs 2.7 pounds, compared to 6 pounds for the first generation Optune System. The company designed its second generation Optune System for everyday life. Novocure plans to convert all U.S. patients who wish to use the new device within three months. All new patients will receive the second generation Optune System. Novocure’s Device Support Specialists (DSSs) train each patient individually on the new device’s features.
“Our DSSs are an integral part of our patient-forward mission and assist patients on an ongoing basis,” said Pritesh Shah, Novocure’s Senior Vice President, Americas. “Since we received U.S. FDA approval for our second generation Optune System, our DSSs have worked hard to meet with existing patients as quickly as possible to convert them to the new device.”
In July 2016, Daniel Torres, 61, of Chicago, was one of the first U.S. patients to convert to Novocure’s second generation Optune System. He says that the enhanced carrying comfort of the smaller, lighter device is an important feature for him when he takes walks with his family and helps his wife, Silvia, with household chores.
“Today is a happy day for us,” Silvia Torres said when Daniel received his second generation Optune System. “It’s a day to give thanks to all of Novocure. We know they are always there for us.”
“We keep the patient at the heart of what we do every day,” said Novocure CEO Asaf Danziger. “FDA approval of our second generation Optune System was a big moment for us as a company as we believe it is tremendously important for our patients. I could not be more proud of how well our team prepared for the rollout of our second generation Optune System and of how diligently they are working to get the new device to our patients.”
About Glioblastoma Multiforme
Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. This means that GBM tumors begin in the brain, rather than traveling to the brain from other parts of the body, such as the lungs or breasts. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in adults than children and to affect men than women.
Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. 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 Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
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.
Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
Important Safety Information
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.
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