Novocure Update on FDA Application for Optune Mya® for Brain Metastases from NSCLC

  Novocure (Nasdaq: NVCR) announced today that it has received a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) in response to its Premarket Approval (PMA) application for Optune Mya® for the treatment of adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.

The Not Approvable Letter indicates that the FDA determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval of the PMA application. The FDA did not raise concerns related to the safety profile of Optune Mya. Novocure is evaluating the feedback and plans to meet with the FDA to determine if there are any options that would support approval of the PMA application that would not require additional clinical studies. There can be no assurance that these discussions or any future submissions regarding this PMA application will lead to an approval.

https://investor.novocure.com/news-releases/news-release-details/novocure-provides-regulatory-update-us-fda-premarket-approval