FDA declines approval of Novocure's Optune Mya over uncertain clinical benefit

• The FDA issued Novocure a not approvable letter for Optune Mya, blocking its premarket approval application.
• The application covers adults with brain metastases from non-small cell lung cancer following stereotactic radiation.
• Uncertainty over the degree of clinical benefit prevented approval; the FDA raised no safety concerns.
• Novocure plans to meet with the FDA to explore potential approval options without additional clinical studies.

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