NovoCure Limited filed a current report on November 9, 2026, disclosing that the U.S. Food and Drug Administration issued a Not Approvable Letter for the company's Premarket Approval application for Optune Mya in a brain metastases indication.

Key Highlights

  • Not Approvable Letter received: The FDA issued the letter in response to NovoCure's PMA application for Optune Mya for adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.
  • Reason cited by FDA: According to the filing, the FDA determined that "uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the PMA application."
  • No safety concerns raised: The filing states the FDA did not raise concerns related to the safety profile of Optune Mya.
  • Next steps planned: NovoCure disclosed it is evaluating the feedback and plans to meet with the FDA to determine if options exist that would support approval without requiring additional clinical studies.
  • No assurance of approval: The filing states "there can be no assurance that these discussions or any future submissions regarding this PMA application will lead to an approval."

FDA Rejects NovoCure's PMA Application for Optune Mya in Brain Metastases

NovoCure Limited, a commercial-stage oncology company incorporated in Jersey that develops tumor treating fields therapy, disclosed on November 9, 2026 that it received a Not Approvable Letter from the FDA concerning its Premarket Approval application for Optune Mya. The application sought approval for the treatment of adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation. The ordinary shares of NovoCure trade on NASDAQ:NVCR.

According to the filing, the FDA's Not Approvable Letter cited uncertainty around the degree of clinical benefit as the basis for not approving the PMA application. The agency did not, however, raise any concerns regarding the safety profile of the device. NovoCure disclosed that it is evaluating the FDA's feedback and intends to request a meeting with the agency to explore whether a path to approval exists that would not require additional clinical studies. The filing carries the company's cautionary statement that no assurance can be given that such discussions or future submissions will result in an approval.

The report was filed under Item 7.01 Regulation FD Disclosure and was signed by Christoph Brackmann, Chief Financial Officer of NovoCure Limited. The company noted that the information in the current report is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, except as expressly set forth by specific reference in a subsequent filing.

What Was Disclosed

NovoCure disclosed receipt of an FDA Not Approvable Letter for Optune Mya's PMA application in the brain metastases from non-small cell lung cancer indication, with the FDA citing uncertainty around clinical benefit and raising no safety concerns. The company plans to engage with the FDA on potential next steps.