US FDA declines to approve Novocure's lung cancer device

Nov 9 (Reuters) - Novocure NVCR.O said on Monday the US health regulator has declined to approve its device for patients whose lung cancer has spread to the brain.

• The company had submitted an application seeking approval for Optune Mya — the device meant for adults with brain tumors from non-small cell lung cancer who have already had stereotactic radiation, a precise form of radiation treatment

• The US Food and Drug Administration was unsure about how much clinical benefit the device could provide to patients, according to the company's release

• The agency did not raise safety concerns, the cancer treatment device maker said

• Novocure had reported in 2024 that a late-stage trial met its main goal of delaying brain tumor growth in lung cancer patients, but preliminary results for overall survival did not reach statistical significance

• Optune Mya uses the company's tumor treating fields technology, which delivers electric fields designed to disrupt cancer cell growth

• Novocure said it was reviewing the FDA's feedback and plans to meet with the agency to see whether there are any options that would support the approval of its application without requiring additional clinical studies