Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
TTFields therapy (Optune) is a NovoCure Limited program in brain metastases from non-small cell lung cancer (PMA, Breakthrough Device). Its PDUFA date is Q4 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Brain metastases from non-small cell lung cancer (PMA, Breakthrough Device). Sponsor: NovoCure Limited (NVCR). Review status: PMA under FDA review; company guides decision in Q4 2026 Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is TTFields therapy (Optune)'s next FDA decision or readout?
TTFields therapy (Optune)'s PDUFA date is Q4 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at TTFields therapy (Optune)'s most recent FDA decision?
No FDA decision for TTFields therapy (Optune) is in our archive yet.
What is TTFields therapy (Optune) used for?
In our records TTFields therapy (Optune) is under review or in development for Brain metastases from non-small cell lung cancer (PMA, Breakthrough Device).
Who makes TTFields therapy (Optune)?
NovoCure Limited (NVCR).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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