Novocure said Monday that the U.S. Food and Drug Administration declined to approve Optune Mya, a wearable device the company sought for adults whose non-small cell lung cancer has spread to the brain after stereotactic radiation^1,2.

In a company release carried by Business Wire, Novocure said the agency issued a Not Approvable Letter on its premarket approval application because of uncertainty about the degree of clinical benefit, and that the FDA did not raise safety concerns about the device².

Reuters, citing the company, reported the same decision and noted that a late-stage trial Novocure described in 2024 met its main goal of delaying brain tumor growth, while preliminary overall survival results did not reach statistical significance¹.

Optune Mya uses Novocure's tumor treating fields technology, which delivers electric fields intended to disrupt cancer cell growth¹.

Novocure said it is reviewing the FDA's feedback and plans to meet with the agency to see whether any options could support approval without additional clinical studies^1,2.

The company, which is listed on Nasdaq as NVCR and is based in Baar, Switzerland, said there can be no assurance that those discussions or future submissions will lead to approval².

The FDA did not issue a public statement in the materials reviewed for this report^1,2.