Anito-cel (anitocabtagene autoleucel) for Relapsed/refractory multiple myeloma
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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. A one-time BCMA-directed CAR T cell therapy from Kite, a Gilead company, which bought Arcellx outright in April 2026. The application covers people whose myeloma has come back after at least 3 prior lines of treatment. In the pivotal iMMagine-1 study, 96% of 117 treated patients responded.
About the drug
Anito-cel: autologous CAR T cell therapy that targets BCMA on myeloma cells using a compact synthetic binder called a D-Domain. Our full Anito-cel profile covers how it works, side effects in plain language, and its trial history.
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 date (PDUFA date) for Anito-cel in Relapsed/refractory multiple myeloma is December 23, 2026.
Who disclosed it: Gilead / Arcellx. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Gilead announcement
What is Anito-cel being reviewed for?
Gilead / Arcellx submitted a BLA for Anito-cel in Relapsed/refractory multiple myeloma.
What to know: A one-time BCMA-directed CAR T cell therapy from Kite, a Gilead company, which bought Arcellx outright in April 2026. The application covers people whose myeloma has come back after at least 3 prior lines of treatment. In the pivotal iMMagine-1 study, 96% of 117 treated patients responded.
How it works: Autologous CAR T cell therapy that targets BCMA on myeloma cells using a compact synthetic binder called a D-Domain.
More: the Anito-cel drug page explains it in plain language.
What did the Anito-cel trials show?
iMMagine-1 (NCT05396885) is the pivotal Phase 2 study, open label and single arm, in 117 treated patients with relapsed or refractory myeloma who had received at least 3 prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody, and whose disease had stopped responding to their last treatment; 87% were triple refractory and 41% penta refractory. At the October 7, 2025 data cutoff, after a median follow-up of 15.9 months, the overall response rate by independent review was 96%, 74% reached a stringent complete response or complete response, and 95% of the 96 patients tested for minimal residual disease had none detectable at a sensitivity of 1 in 100,000 cells.
More: the Anito-cel drug page has the full trial history and sources.
What are the side effects of Anito-cel?
Side effects in iMMagine-1 followed the pattern of other CAR T therapies. Cytokine release syndrome, the fever-and-low-blood-pressure reaction that follows CAR T infusion, occurred in 86% of patients but was mostly mild: 83% of patients had either no CRS or grade 1 CRS, meaning fever only.
More: the Anito-cel drug page lists the warnings in full.
How much will Anito-cel cost?
Gilead / Arcellx has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Anito-cel decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
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 daily.