Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
Anito-cel (anitocabtagene autoleucel) is a Gilead Sciences, Inc. program in relapsed or refractory multiple myeloma (fourth-line), BCMA CAR-T. Its PDUFA date is Dec 23, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Relapsed or refractory multiple myeloma (fourth-line), BCMA CAR-T. Sponsor: Gilead Sciences, Inc. (GILD). Review status: BLA accepted; pivotal Phase 2 iMMagine-1 Market-cap tier at the time we tracked it: Large. 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 Anito-cel (anitocabtagene autoleucel)'s next FDA decision or readout?
Anito-cel (anitocabtagene autoleucel)'s PDUFA date is Dec 23, 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 Anito-cel (anitocabtagene autoleucel)'s most recent FDA decision?
No FDA decision for Anito-cel (anitocabtagene autoleucel) is in our archive yet.
What is Anito-cel (anitocabtagene autoleucel) used for?
In our records Anito-cel (anitocabtagene autoleucel) is under review or in development for Relapsed or refractory multiple myeloma (fourth-line), BCMA CAR-T.
Who makes Anito-cel (anitocabtagene autoleucel)?
Gilead Sciences, Inc. (GILD).
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
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