FDA拒绝批准Novocure肺癌脑转移器械Optune Mya：临床获益程度尚不确定
华盛顿 — 美国食品药品监督管理局（FDA）拒绝批准 Novocure 公司的 Optune Mya 器械用于肺癌脑转移治疗。Novocure（纳斯达克：NVCR）11月9日宣布，公司收到 FDA 就 Optune Mya 市前批准（PMA）申请发出的「不可批准函」，这项申请寻求把这款器械用于已经接受立体定向放射治疗的非小细胞肺癌脑转移成年患者。
FDA 在函中表示，Optune Mya 能带来的临床获益程度存在不确定性，这是这项申请无法获批的原因。Novocure 说，FDA 没有对 Optune Mya 的安全性提出疑虑，这次决定针对的是获益幅度，而不是安全问题。
Optune Mya 采用 Novocure 的肿瘤治疗电场技术，通过电场干扰癌细胞的分裂与生长。据路透社报道，Novocure 2024 年报告的一项后期临床试验达到了主要目标，可以延缓肺癌患者脑部肿瘤的生长，但总生存期的初步结果没有达到统计学上的显著性。
Novocure 表示，公司正在评估 FDA 的反馈，并计划与 FDA 会面，商讨是否存在一条不需要增加新的临床研究、也能支持批准这项申请的路径。公司同时提醒，这类讨论以及今后任何新的提交，都不能保证这项申请最终获批。
Novocure 是一家全球肿瘤公司，致力于以肿瘤治疗电场疗法，为部分侵袭性最强的癌症患者延长生存，其相关产品此前已在美国获批用于胶质母细胞瘤等适应症。
FDA Declines to Approve Novocure's Optune Mya for Lung Cancer Brain Metastases, Citing Uncertain Clinical Benefit
WASHINGTON — The U.S. Food and Drug Administration (FDA) has declined to approve Novocure's Optune Mya device for treating brain metastases from lung cancer. Novocure (Nasdaq: NVCR) announced on November 9 that it had received a Not Approvable Letter from the FDA in response to its Premarket Approval (PMA) application for Optune Mya, which sought approval to treat adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.
The FDA said in the letter that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the application. Novocure said the FDA did not raise concerns related to the safety profile of Optune Mya, and that the decision turned on the extent of benefit rather than safety.
Optune Mya uses Novocure's Tumor Treating Fields technology, which delivers electric fields designed to disrupt cancer cell division and growth. According to Reuters, a late-stage trial reported by Novocure in 2024 met its main goal of delaying brain tumor growth in lung cancer patients, but preliminary results for overall survival did not reach statistical significance.
Novocure said it is evaluating the FDA's feedback and plans to meet with the agency to determine whether there are options that would support approval of the application without requiring additional clinical studies. The company cautioned that there can be no assurance that these discussions or any future submissions will lead to an approval.
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through its Tumor Treating Fields therapy, whose products have previously been approved in the United States for indications including glioblastoma.
来源：Novocure
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品监督管理局（FDA）位于马里兰州 Silver Spring 的 White Oak 园区总部大楼（FDA 官方照片，公共领域；本站联邦核心图库固定图）。 / Photo: FDA headquarters at the White Oak campus in Silver Spring, Maryland (U.S. Food and Drug Administration photo, public domain; GSM federal asset library).
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