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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 the FDA is deciding on Anito-cel for Relapsed/refractory multiple myeloma
The FDA is reviewing Gilead / Arcellx's application to approve Anito-cel (anitocabtagene autoleucel) for 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.
Who the Anito-cel decision matters to
Multiple myeloma is a cancer of plasma cells, the white blood cells that make antibodies. Abnormal plasma cells crowd the bone marrow, weaken bones and release a useless protein that can damage the kidneys.
More than a dozen drugs are approved, and 2 more are under FDA review: the CAR T cell therapy anito-cel, with a decision due December 23, 2026, and the oral drug mezigdomide, due May 13, 2027.
Prevalence: About 36,000 new US diagnoses expected in 2026 and roughly 203,000 people living with it, which puts myeloma right at the edge of the US rare disease threshold; it is 1.7% of all new cancers (NCI SEER). See our full Multiple Myeloma page for current treatments, recruiting trials, and community resources.
How Anito-cel works
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 an approval or a rejection of Anito-cel 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. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Multiple Myeloma treatment stands today
Read our full Multiple Myeloma treatment summary
Myeloma is one of the busiest trial fields in all of cancer, with hundreds of recruiting studies, so the question is rarely whether a trial exists but which one fits the number and type of treatments you have already had.
The approved drugs fall into classes that trials combine and sequence: proteasome inhibitors (bortezomib, carfilzomib, ixazomib), immunomodulators (thalidomide, lenalidomide, pomalidomide), antibodies such as daratumumab and elotuzumab, high-dose chemotherapy with a stem cell transplant, and newer immune therapies, including CAR T cell therapies and bispecific antibodies, that aim the body's T cells at myeloma cells.
Two FDA decisions are on the calendar. Anito-cel (anitocabtagene autoleucel), a BCMA-directed CAR T cell therapy from Kite, a Gilead company, and Arcellx, is under review as a fourth-line treatment for relapsed or refractory myeloma, with a decision due December 23, 2026, based on the Phase 2 iMMagine-1 study (NCT05396885).
Mezigdomide, an oral drug from Bristol Myers Squibb that works by breaking down 2 proteins myeloma cells depend on, is under review in combination with carfilzomib and dexamethasone, with a decision due May 13, 2027; in the Phase 3 SUCCESSOR-2 trial of 479 patients it kept the disease from progressing for a median of 18.0 months versus 8.3 months without it.
Many myeloma trials are written for people who have already been treated with the 3 main drug classes. A myeloma specialist can read your treatment history against those rules in a single visit, and the International Myeloma Foundation's InfoLine and HealthTree's trial matching tool both help patients do the first pass themselves.
The Multiple Myeloma page has every treatment and trial →Meanwhile, 714 Multiple Myeloma studies are open or about to open
Whatever the FDA decides here, research on Multiple Myeloma does not stop. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Multiple Myeloma. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
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.
Is there already an FDA-approved treatment for Multiple Myeloma?
Trial Friend does not have pages yet for the FDA-approved drugs for Multiple Myeloma, if there are any. The Multiple Myeloma page checks FDA drug labels for approved treatments.
Also coming: Mezigdomide.
Check: the Multiple Myeloma page also searches FDA drug labels for approved treatments.
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 has the safety details reported so far.
Can I get Anito-cel before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 714 Multiple Myeloma studies are open or about to open. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Gilead / Arcellx directly. Registered programs are listed on ClinicalTrials.gov.
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.