Health

FDA declines to approve Novocure's lung cancer device for brain tumors, citing uncertain benefit

Washington • November 9, 2026 • By Press Pass USA

Novocure's Optune wearable device, which delivers electric fields to disrupt cancer cell growth

Photo: BioWorld (file photo)

The U.S. Food and Drug Administration has declined to approve Novocure's Optune Mya, a wearable device meant to treat brain tumors in patients whose lung cancer has spread to the brain, the company said Monday — a setback for a treatment aimed at one of the hardest complications of lung cancer.

Novocure said the FDA issued a Not Approvable Letter in response to its premarket approval application for Optune Mya, for adults with brain metastases from non-small cell lung cancer who have already had stereotactic radiation, a precise form of radiation treatment.

The agency determined that uncertainty around the degree of clinical benefit provided by the device prevented approval, according to the company. The FDA did not raise concerns about the safety profile of Optune Mya.

Optune Mya uses Novocure's Tumor Treating Fields technology, which delivers low-intensity electric fields through a wearable device to disrupt cancer cell growth. Novocure reported in 2024 that a late-stage trial of the therapy 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 reviewing the FDA's feedback and plans to meet with the agency to determine whether there are any options that would support approval of the application without requiring additional clinical studies. The company said there is no assurance that those discussions, or any future submissions, will lead to an approval.

Brain metastases — cancer that spreads from the lungs to the brain — are a common and serious complication of non-small cell lung cancer, the most common form of the disease, and treatment options after radiation remain limited.

Sources: Reuters, “US FDA declines to approve Novocure's lung cancer device” (Nov. 9, 2026); Novocure, “Novocure Provides Regulatory Update on U.S. FDA Premarket Approval Application for Optune Mya® for Brain Metastases from Non-Small Cell Lung Cancer” (Nov. 9, 2026); Novocure SEC filing (Form 8-K, Nov. 9, 2026).