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.
Source: Novocure
Published by GSM · USA (original Chinese edition)
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