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# Novocure Gets Rejection Letter on Lung Cancer Device
- URL: https://www.fdaweb.com/novocure-gets-rejection-letter-on-lung-cancer-device/
- Published: 2026-11-09T23:06:27.000Z
- Updated: 2026-11-09T23:06:27.000Z
- Author: David McFarland
- Tags: Devices

FDA has issued Novocure a Not Approvable Letter for its PMA for Optune Mya for treating adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.

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

Novocure says it plans to meet with FDA to determine if there are any options that would support approval and not require additional clinical studies.

The experimental wearable medical device is designed to deliver tumor treating fields, which are described as low-intensity, alternating electrical fields applied via adhesive arrays on the skin to disrupt rapid cancer cell division.