Anito-cel (anitocabtagene autoleucel) for Relapsed/refractory multiple myeloma
The FDA is expected to decide on Anito-cel for Relapsed/refractory multiple myeloma by December 23, 2026, under a BLA from Gilead / Arcellx.
What is being decided
Gilead / Arcellx has a BLA under FDA review for Anito-cel (anitocabtagene autoleucel) in Relapsed/refractory multiple myeloma. BCMA-directed CAR T cell therapy.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
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Frequently asked questions
When will the FDA decide on Anito-cel?
The FDA's target decision date (PDUFA date) for Anito-cel in Relapsed/refractory multiple myeloma is December 23, 2026, disclosed by Gilead / Arcellx. The agency can act before this date and occasionally runs past it.
What is Anito-cel being reviewed for?
Gilead / Arcellx submitted a BLA for Anito-cel in Relapsed/refractory multiple myeloma. BCMA-directed CAR T cell therapy.
What happens after the Anito-cel decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Gilead announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.