ROOT, Switzerland--(BUSINESS WIRE)--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).

瑞士ROOT——（商业新闻短讯）——Novocure（纳斯达克：NVCR）今天宣布，美国食品和药物管理局（FDA）批准其新的头部柔性电极（HFE）换能器阵列与Optune Gio®一起用于治疗成人多形性胶质母细胞瘤（GBM）患者。

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..

Optune Gio是一种可穿戴的便携式设备，可产生称为肿瘤治疗场（TTFields）的交变电场，该电场通过非侵入性可穿戴阵列传递。TTFields对分裂癌细胞的带电成分施加物理力，从而破坏癌细胞表现出的快速细胞分裂。。

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.

新的HFE阵列使用柔性聚合物材料代替当前Optune Gio阵列中使用的陶瓷盘，使其轻三分之一，薄50%。

“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.

Novocure首席运营官Mukund Paravasthu表示：“在Novocure，我们认识到产品创新必须为患者带来有意义的结果。”。“最新FDA批准的HFE阵列更轻、更薄，旨在为患者带来更舒适、更明显的益处。我们期待着在美国推出新阵列。

and will continue our work to deliver product innovations that prioritize the needs of people using our treatments.”.

并将继续我们的工作，以提供产品创新，优先考虑使用我们治疗的人的需求。”。

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.

Novocure计划通过受控过渡计划，在2025年上半年之前将美国的Optune Gio用户转换为新的HFE阵列。

Important Safety Information

重要安全信息

What is Optune Gio® approved to treat?

Optune Gio®批准用于治疗什么？

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.

Optune Gio是一种可穿戴、便携式、FDA批准的设备，用于治疗22岁或以上的成年患者的一种称为多形性胶质母细胞瘤（GBM）的脑癌。

Newly diagnosed GBM

新诊断的GBM

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

如果您有新诊断的GBM，Optune Gio与一种称为替莫唑胺（TMZ）的化疗联合使用，如果：

Your cancer is confirmed by your healthcare professional AND

您的癌症已由您的医疗保健专业人员确认

You have had surgery to remove as much of the tumor as possible

你做了手术，尽可能多地切除了肿瘤

Recurrent GBM

复发性GBM

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

如果您的肿瘤复发，Optune Gio可以单独用作标准药物治疗的替代品，如果：

You have tried surgery and radiation and they did not work or are no longer working AND

你尝试过手术和放射治疗，但它们不起作用或不再起作用

You have tried chemotherapy and your GBM has been confirmed by your healthcare professional

您已经尝试过化疗，您的GBM已经由您的医疗保健专家确认

Who should not use Optune Gio?

谁不应该使用Optune Gio？

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

Optune Gio不适合所有人。如果您有以下情况，请咨询您的医生：

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.

植入的医疗器械（可编程分流器），颅骨缺损（无需更换的骨骼缺失）或子弹碎片。Optune Gio尚未在植入电子设备的人群中进行测试，这可能会导致设备无法正常工作，而Optune Gio尚未在颅骨缺损或子弹碎片的人群中进行测试，这可能会导致Optune Gio无法正常工作。

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

。当Optune Gio接触皮肤时，它可能会引起更多的发红和瘙痒，或者很少引起危及生命的过敏反应

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.

如果您怀孕或计划怀孕，请不要使用Optune Gio。目前尚不清楚Optune Gio在怀孕期间是否安全或有效。

What should I know before using Optune Gio?

在使用Optune Gio之前，我应该知道什么？

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.

Optune Gio只能在接受合格人员的培训后使用，例如您的医生、护士或其他完成了Optune Gio制造商Novocure®提供的培训课程的医务人员。

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

不要使用Novocure寄给您或医生给您的Optune Gio治疗套件中没有的任何部件

Do not get the device or transducer arrays wet

不要弄湿设备或传感器阵列

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

如果您的头皮有潜在的严重皮肤病，请与医生讨论这是否可以预防或暂时干扰Optune Gio治疗

What are the possible side effects of Optune Gio?

Optune Gio可能有哪些副作用？

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.

与化疗（替莫唑胺或TMZ）一起使用时，Optune Gio最常见的副作用是血小板计数低，恶心，便秘，呕吐，疲倦，装置引起的头皮刺激，头痛，癫痫发作和抑郁症。单独使用Optune Gio时最常见的副作用是头皮刺激（发红和发痒）和头痛。

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..

其他副作用是不适，肌肉抽搐，跌倒和皮肤溃疡。如果您有任何这些副作用或问题，请咨询您的医生。。

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

有关设备的适应症、禁忌症、警告和注意事项的完整信息，请单击此处获取Optune Gio使用说明（IFU）。

About Tumor Treating Fields

关于肿瘤治疗领域

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.

肿瘤治疗场（TTFields）是通过多种机制施加物理力杀死癌细胞的电场。TTFields不会显着影响健康细胞，因为它们具有与癌细胞不同的特性（包括分裂速率，形态和电特性）。

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.

这些多种不同的机制共同作用以靶向和杀死癌细胞。由于这些多机制作用，TTFields治疗可以在批准的适应症中添加到癌症治疗模式中，并且在临床前模型中与化疗，放疗，免疫检查点抑制或靶向治疗一起使用时，可以在实体瘤类型中显示出增强的效果。

TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors..

TTFields疗法提供了临床多功能性，有可能帮助解决一系列实体瘤的治疗挑战。。

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

要了解更多关于TTFields疗法及其对癌细胞的多方面影响，请访问tumortreatingfields.com。

About Novocure

关于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是一家全球性肿瘤公司，致力于通过其创新疗法，肿瘤治疗领域的开发和商业化，延长一些最具侵袭性的癌症的生存期。Novocure的商业化产品在某些国家被批准用于治疗成人胶质母细胞瘤，非小细胞肺癌，恶性胸膜间皮瘤和胸膜间皮瘤患者。

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还有几项正在进行或已完成的临床试验，探索使用肿瘤治疗场治疗胶质母细胞瘤，非小细胞肺癌和胰腺癌。。

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.

Novocure 全球总部位于瑞士罗特，美国总部位于新罕布什尔州朴茨茅斯，研发机构位于以色列海法。