FDA issues Not Approvable Letter for Novocure's Optune Mya PMA in NSCLC brain metastases

NovoCure Ltd

FDA determined uncertainty around degree of clinical benefit of Optune Mya prevented approval; no safety concerns were raised.
Optune Mya sought approval for adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.
Novocure plans to meet with the FDA to explore options for approval that would not require additional clinical studies.
Company said there can be no assurance that discussions or future submissions will lead to approval; announced November 9, 2026.

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