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

NVCR
  • Novocure received a Not Approvable Letter from the U.S. FDA regarding its Premarket Approval application for Optune Mya for treating adult brain metastases from non-small cell lung cancer following stereotactic radiation.
  • The FDA determined that uncertainty surrounding the degree of clinical benefit prevented approval, though no safety concerns were raised.
  • Novocure is evaluating the feedback & plans to meet with the FDA to explore potential approval options that would not require additional clinical studies.
  • There is no assurance that discussions or future submissions will result in approval of the PMA application.
  • Novocure's commercialized products are currently approved in certain countries for glioblastoma, pancreatic cancer, non-small cell lung cancer, & malignant pleural mesothelioma.