Novocure Provides Regulatory Update on U.S. FDA Premarket Approval Application for Optune Mya® for Brain Metastases from Non-Small Cell Lung Cancer

Uncertainty about clinical benefit prevented approval; the FDA did not raise safety concerns.

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BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (Nasdaq: NVCR) announced today that it has received a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) in response to its Premarket Approval (PMA) application for Optune Mya^® for the treatment of adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.

The Not Approvable Letter indicates that the FDA determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the PMA application. The FDA did not raise concerns related to the safety profile of Optune Mya. Novocure is evaluating the feedback and plans to meet with the FDA to determine if there are any options that would support approval of the PMA application that would not require additional clinical studies. There can be no assurance that these discussions or any future submissions regarding this PMA application will lead to an approval.

About 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, pancreatic cancer, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. 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’s global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X.

Forward-Looking Statements

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 trial 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. 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 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 26, 2026, and subsequent filings 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261109483647/en/

Investors:
Adam Daney
investorinfo@novocure.com

Media:
Catherine Falcetti
media@novocure.com

Source: Novocure

Key Terms

premarket approval (pma) regulatory

Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.

not approvable letter regulatory

A not approvable letter is a formal communication from a U.S. regulatory authority (commonly the FDA) telling a drug, biologic or device sponsor that the current marketing application cannot be approved as submitted. It lists the substantive deficiencies—such as missing data, unresolved safety or efficacy concerns, or manufacturing issues—and typically explains what additional studies, analyses, or changes would be required before approval can be reconsidered; it does not authorize marketing and does not specify a guaranteed path to approval.

brain metastases medical

Cancer cells that have spread from another part of the body to the brain, forming new tumors there. Think of it like weeds from one garden taking root in another; the behavior and treatment needs can change significantly once cancer reaches the brain. For investors, brain metastases matter because they often drive different clinical trial designs, higher healthcare costs, and urgent demand for effective therapies, all of which can materially affect a biotech or healthcare company’s prospects.

stereotactic radiation medical

A form of targeted radiation therapy that delivers highly focused beams to a precisely mapped, small area of tissue using stereotactic (three‑dimensional coordinate) guidance and advanced imaging. It achieves a high radiation dose to the target while minimizing exposure to surrounding healthy tissue; treatments are given as one or a few high‑dose sessions (commonly called stereotactic radiosurgery for the brain and stereotactic body radiotherapy for other sites) and are limited by lesion size, location, and proximity to sensitive structures.