Novocure Provides Regulatory Update on U.S. FDA Premarket Approval Application for Optune Mya® for Brain Metastases from Non-Small Cell Lung Cancer

BAAR, Switzerland--(BUSINESS WIRE)--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