On Nov. 9, FDA Issues Non-Approval Letter for Optune Mya to Treat Brain Metastases
Key Facts
NovoCure said on Nov. 9, 2026, that it had received a letter from the U.S. Food and Drug Administration stating that its premarket approval application for the Optune Mya device was "not approvable." The application covers treatment for adults with brain metastases from non-small cell lung cancer after stereotactic radiation. The letter presents a regulatory hurdle for the device’s path to the U.S. market, where the company had hoped to launch it. But the company did not describe the action as a final rejection and said it plans to discuss the agency’s comments and available options with it. Its disclosure did not specify when those discussions would take place.
According to the company’s disclosure, the agency linked its decision to uncertainty about the degree of clinical benefit the device provides, saying that uncertainty prevented approval of the application. NovoCure added that the FDA raised no concerns about the safety profile. This explanation separates two distinct questions in the device review: how safe it is and how clear its therapeutic benefit is. The agency’s comment, as described by the company, focuses on the second question and does not mean the agency confirmed the device’s efficacy to the level required for approval. The disclosure provided no further details about the data the agency relied on to assess benefit.
NovoCure submitted the approval application in late 2025, following results from a pivotal trial that, according to MedTech Dive, showed delayed progression of brain metastases compared with best supportive care. But the coverage said the trial showed no difference in secondary endpoints, including neurocognitive failure, overall survival and radiographic response of lesions. The contrast between the result on metastasis progression and the secondary outcomes provides context for the agency’s concern about the degree of clinical benefit. In September 2025, the company presented final data from the Phase 3 METIS trial at the American Society for Radiation Oncology meeting. The trial included adults with one to 10 brain metastases from non-small cell lung cancer after stereotactic radiosurgery.
Optune Mya uses low-intensity electric fields to disrupt cancer cells’ ability to grow and divide, according to MedTech Dive. The use covered by the approval application is limited to adults with brain metastases from non-small cell lung cancer after stereotactic radiation. The FDA had granted the tumor treating fields technology Breakthrough Device designation for this use in 2024, before the marketing approval application was submitted. MedTech Dive reported that Executive Chairman William Doyle told investors in late October that the company had hoped to secure approval before year-end. An early 2027 launch was the company’s target at the time, according to the coverage.
NovoCure said it plans to meet with the agency to find out whether there are options to support approval without additional clinical studies. It added that the discussions or any future applications do not guarantee approval. The device’s regulatory path therefore remains tied to the outcome of the review of the agency’s comments, while the company has announced no outcome or new timeline. In a separate earnings disclosure, NovoCure said third-quarter 2026 revenue was $193.4 million, up 16% from the same period in 2025. The company attributed the increase mainly to 19% growth in the number of active patients worldwide.
EL7 data showed that NovoCure shares, trading under the ticker NVCR, closed at $12.53 in the Nov. 9 session. The price data do not specify the closing time relative to the company’s announcement that day. The closing price alone therefore does not show the direction of the market’s response to the regulatory letter. The available facts also do not include a daily comparison or percentage change for the stock in the session. The figure remains the closing price for that day, alongside the company’s announcement that it had received the agency’s letter.