ROOT, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today announced that its Premarket Approval (PMA) application seeking approval for the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of non-small cell lung cancer (NSCLC), following progression on or after platinum-based therapy, has been accepted for filing by the U.S.

瑞士ROOT——（商业新闻短讯）——Novocure（纳斯达克：NVCR）今天宣布，其上市前批准（PMA）申请寻求批准使用肿瘤治疗场（TTFields）疗法以及标准全身疗法治疗非小细胞肺癌（NSCLC），继铂类疗法进展或之后，已被美国接受备案。

Food and Drug Administration (FDA)..

美国食品和药物管理局（FDA）。。

“We are thrilled to announce the FDA has accepted our PMA application for review of the LUNAR data in NSCLC,” said Asaf Danziger, Novocure’s Chief Executive Officer. “This significant milestone brings us one step closer to treating patients seeking treatment for NSCLC, post-platinum, for which very few effective non-toxic options exist today.

Novocure首席执行官阿萨夫·丹泽格（AsafDanziger）表示：“我们很高兴地宣布，FDA已接受我们的PMA申请，以审查非小细胞肺癌的月球数据。”。“这一重要里程碑使我们离治疗寻求非小细胞肺癌（NSCLC）治疗的患者更近了一步，铂类药物治疗后，目前几乎没有有效的无毒选择。

I would like to thank our investigators and patients, as well as our Novocure colleagues, for their dedication in pursuit of bringing our novel therapy to thousands of patients in need.”.

我要感谢我们的研究人员和患者，以及我们的Novocure同事，感谢他们致力于将我们的新疗法带给成千上万需要的患者。”。

The PMA application for LUNAR was submitted with a filing date of December 15, 2023, and is now under substantive review by the FDA. Novocure expects to receive a regulatory decision from FDA in second half 2024.

月球PMA申请提交日期为2023年12月15日，目前正在接受FDA的实质性审查。Novocure预计将于2024年下半年收到FDA的监管决定。

About LUNAR

关于LUNAR

LUNAR tested the safety and effectiveness of TTFields therapy when used together with either an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients diagnosed with metastatic NSCLC following progression on or after the use of platinum-based therapy. Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median overall survival (OS) of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139).

LUNAR测试了TTFields治疗的安全性和有效性，当与免疫检查点抑制剂（ICI）或多西紫杉醇一起用于治疗使用铂类治疗后或使用铂类治疗后诊断为转移性NSCLC的患者时。随机接受TTFields治疗和标准治疗的患者（n=137）显示中位总生存期（OS）为13.2个月，而仅接受标准治疗的患者（n=139）为9.9个月。

Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71).

随机接受TTFields治疗和医生选择的ICI（n=66）的患者，单用ICI治疗的患者中位OS为18.5个月，中位OS为10.8个月（n=68；HR=0.63；P=0.03）。随机接受TTFields治疗和多西他赛（n=71）的患者生存率呈阳性趋势，中位OS为11.1个月，而单用ICI治疗的患者为8.7个月单独使用多西紫杉醇（n=71）。

TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events..

TTFields治疗耐受性良好，无额外的全身毒性，3级（无4级或5级）器械相关不良事件很少。。

About NSCLC

关于非小细胞肺癌

Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease.

肺癌是全球癌症相关死亡的最常见原因，NSCLC约占所有肺癌的85%。据估计，美国每年约有193000名患者被诊断出患有NSCLC。医生根据疾病的阶段，使用不同的手术，放疗和药物治疗组合来治疗NSCLC。

Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly.

手术通常用于疾病的早期阶段，可能对一部分患者有疗效。自1991年以来，联合铂类化疗药物的放疗一直是局部晚期或转移性非小细胞肺癌的一线治疗标准。某些免疫检查点抑制剂已被批准用于非小细胞肺癌的一线治疗，这种情况下的护理标准似乎正在迅速发展。

The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, docetaxel, immune checkpoint inhibitors or pemetrexed..

二线治疗的护理标准也在不断发展，可能包括接受免疫检查点抑制剂作为一线方案的患者的铂类化疗，多西紫杉醇，免疫检查点抑制剂或培美曲塞。。

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, 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，恶性胸膜间皮瘤和胸膜间皮瘤患者。

Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer..

Novocure正在进行或完成临床试验，研究脑转移瘤，胃癌，胶质母细胞瘤，肝癌，非小细胞肺癌，胰腺癌和卵巢癌的肿瘤治疗领域。。

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter..

Novocure总部位于瑞士Root，全球足迹不断扩大，在朴茨茅斯、新罕布什尔州和东京设有区域运营中心，在以色列海法设有研究中心。有关该公司的更多信息，请访问Novocure.com，并在LinkedIn和Twitter上关注@Novocure。。

Forward-Looking Statements

前瞻性声明

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.

除了历史事实或现状声明外，本新闻稿可能还包含前瞻性声明。前瞻性声明提供了Novocure目前对未来事件的预期或预测。这些可能包括关于其研究计划预期科学进展、临床研究进展、潜在产品开发、临床结果解释、监管批准前景、制造发展和能力、产品市场前景、覆盖范围、，从第三方付款人处收取的款项以及与非历史事实相关的其他声明。

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, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic 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 23, 2023, and subsequent filings with the U.S.

您可以通过在声明中使用诸如“预期”、“估计”、“预期”、“项目”、“打算”、“计划”、“相信”或其他类似含义的词语和术语来识别其中一些前瞻性声明。由于一般财务、经济、环境、，监管和政治条件以及新型冠状病毒大流行引起的问题以及Novocure面临的其他更具体的风险和不确定性，例如2023年2月23日提交的10-K表格年度报告以及随后向美国提交的文件中所述的风险和不确定性。

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.

证券交易委员会。鉴于这些风险和不确定性，任何或所有这些前瞻性陈述可能被证明是不正确的。因此，您不应依赖任何此类因素或前瞻性陈述。此外，Novocure不打算公开更新任何前瞻性声明，除非法律要求。

Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permit.

本文件中的任何前瞻性声明仅在本文件日期起生效。1995年《私人证券诉讼改革法案》允许。