Dive Brief:
- Novocure has been denied Food and Drug Administration approval for its device intended to treat non-small cell lung cancer that has spread to the brain.
- The FDA’s not approvable letter cited uncertainty around the degree of clinical benefit provided by Novocure’s device, Optune Mya, the company said Monday. The system uses low-energy electrical fields to disrupt cancer cells’ ability to grow and divide.
- The regulator did not raise concerns about the device’s safety profile, Novocure said. The company intends to meet with the FDA to determine if there are other options that would support approval without additional clinical studies.
Dive Insight:
Novocure submitted an application to the Food and Drug Administration in late 2025 following results of a pivotal trial that showed its cancer treatment delayed brain metastasis progression compared with best supportive care. There was no difference in the secondary endpoints, including neurocognitive failure, overall survival or radiological response of brain lesions, measured with MRI.
Novocure has received authorization for its tumor treating fields technology in other indications, including locally advanced pancreatic cancer and non-small cell lung cancer.
Executive Chairman William Doyle told investors in late October that the company hoped to receive FDA approval for Optune Mya by the end of the year, with plans to launch the device in early 2027.
In response to the FDA letter, Novocure said there is no guarantee that its discussions with the regulator or future submissions will lead to approval.
