Novocure Receives FDA 'Not Approvable' Letter for Optune Mya

Novocure received an FDA “Not Approvable” letter for its Optune Mya application to treat adults with brain metastases from non-small cell lung cancer after stereotactic radiation. The FDA cited uncertainty about the therapy’s degree of clinical benefit, but raised no concerns about device safety. Novocure is evaluating the feedback and plans to discuss possible approval paths with the FDA, including options that may not require additional clinical studies; approval is not guaranteed.