US FDA declines to approve Novocure's lung cancer device
NVCR•The FDA declined to approve Novocure's Optune Mya device for adults with brain tumors from non-small cell lung cancer, citing uncertainty about its clinical benefit. The agency raised no safety concerns, and Novocure plans to discuss options with the FDA.
1. FDA declines application
Novocure said the FDA declined to approve Optune Mya for adults with brain tumors from non-small cell lung cancer who have already received stereotactic radiation. The company said the agency was unsure how much clinical benefit the device could provide and did not raise safety concerns.
2. Company seeks next steps
Novocure said it is reviewing the FDA's feedback and plans to meet with the agency about options that could support approval without additional clinical studies. The company reported in 2024 that a late-stage trial met its main goal of delaying brain tumor growth, but preliminary overall-survival results did not reach statistical significance.
