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NVCR PDUFA Date: TTFields therapy

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FDA decision (PDUFA) target November 2026 · NovoCure Limited · Brain metastases from non-small cell lung cancer (PMA, Breakthrough Device)
Primary source: sponsor announcement

Key facts

FDA PDUFA target dateNovember 2026 (window)
Drug / candidateTTFields therapy (Optune)
IndicationBrain metastases from non-small cell lung cancer (PMA, Breakthrough Device)
CompanyNovoCure Limited

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FAQ

When is the NVCR PDUFA date?
The FDA PDUFA target date for NVCR (NovoCure Limited) is November 2026 for TTFields therapy (Optune). The sponsor has guided this window, not a specific day; the date shown is the window, at the precision the source gave. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is NVCR's drug TTFields therapy?
TTFields therapy (Optune) is NovoCure Limited's candidate under FDA review for Brain metastases from non-small cell lung cancer (PMA, Breakthrough Device).