# Anitocabtagene autoleucel (anito-cel) PDUFA Event: Relapsed or refractory multiple myeloma

Canonical URL: https://biopharmsignal.com/pdufa-calendar/GILD/anito-cel-relapsed-refractory-multiple-myeloma

Ticker: GILD

Company: Gilead Sciences

Event date: 2026-12-23

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. FDA assigned an anticipated December 23, 2026 PDUFA action date to the anito-cel BLA.

## Event Timeline

### December 23, 2026 — FDA decision expected

FDA assigned an anticipated December 23, 2026 PDUFA action date to the anito-cel BLA.

[Gilead and Arcellx — BLA acceptance and PDUFA date](https://www.gilead.com/news/news-details/2026/gilead-sciences-to-acquire-arcellx-to-maximize-long-term-potential-of-anito-cel)

### April 28, 2026 — Gilead completed its acquisition of Arcellx

Arcellx became a wholly owned subsidiary of Gilead, giving Gilead full control of anito-cel; Arcellx common stock was subsequently delisted from Nasdaq.

[Gilead — Completion of the Arcellx acquisition](https://www.gilead.com/news/news-details/2026/gilead-sciences-completes-acquisition-of-arcellx-ahead-of-potential-commercial-launch-of-anito-cel)

### February 20, 2026 — FDA accepted the BLA

FDA notified Arcellx that it had accepted the fourth-line-or-later BLA, supported by the Phase 1 study and pivotal Phase 2 iMMagine-1 study, and assigned the December 23, 2026 target action date.

[Arcellx — 2025 annual report confirming BLA acceptance](https://www.sec.gov/Archives/edgar/data/1786205/000119312526076876/aclx-20251231.htm)

### December 23, 2025 — Arcellx and Kite submitted the BLA

The partners submitted the application for anito-cel in fourth-line-or-later relapsed or refractory multiple myeloma, supported by the Phase 1 and pivotal iMMagine-1 studies.

[Arcellx — 2025 annual report confirming BLA submission](https://www.sec.gov/Archives/edgar/data/1786205/000119312526076876/aclx-20251231.htm)

### December 6, 2025 — Updated pivotal iMMagine-1 results were reported

At a median follow-up of 15.9 months, anito-cel produced a 96% overall response rate, a 74% complete or stringent complete response rate and 95% MRD negativity among evaluable patients, with no delayed or non-ICANS neurotoxicity observed.

[Arcellx — Updated pivotal iMMagine-1 results](https://www.arcellx.com/wp-content/uploads/2025/12/12.6.25_Arcellx_iMMagine_1_ASH-Data.pdf)

### June 13, 2025 — Initial pivotal iMMagine-1 results were presented

At a median follow-up of 12.6 months, anito-cel demonstrated a 97% overall response rate, a 68% complete or stringent complete response rate and 93.3% MRD negativity among evaluable patients.

[Arcellx — Initial pivotal iMMagine-1 results at EHA 2025](https://www.arcellx.com/wp-content/uploads/2025/06/Arcellx_EHA_IR-Event_06.13.25_FINAL.pdf)

### December 6, 2024 — Mature Phase 1 results supported the pivotal program

With 38.1 months of median follow-up, the Phase 1 study reported median progression-free survival of 30.2 months and no delayed or non-ICANS neurotoxicity.

[Arcellx — Mature anito-cel Phase 1 results](https://www.arcellx.com/wp-content/uploads/2024/12/Ph-1-Update-for-ASH-2024_4825-vF_120624_corrected.pdf)

### January 30, 2023 — Kite and Arcellx closed their global collaboration

The companies began jointly developing and commercializing the program in the United States, with Kite responsible for commercialization outside the country.

[Arcellx and Kite — Collaboration closing](https://www.sec.gov/Archives/edgar/data/1786205/000119312523018465/d434551dex991.htm)

### July 15, 2022 — Pivotal Phase 2 iMMagine-1 started

The open-label pivotal study began evaluating a single anito-cel infusion in patients with relapsed or refractory multiple myeloma.

[ClinicalTrials.gov — iMMagine-1 study record](https://clinicaltrials.gov/study/NCT05396885)

### December 23, 2019 — First-in-human Phase 1 study started

The Phase 1 study began dose finding and long-term evaluation of the program then known as CART-ddBCMA.

[ClinicalTrials.gov — Anito-cel Phase 1 study record](https://clinicaltrials.gov/study/NCT04155749)

## Regulatory Designations

- Fast Track FDA: [Arcellx — Anito-cel regulatory designations](https://www.sec.gov/Archives/edgar/data/1786205/000119312522301426/d420020dex991.htm)

- Orphan Drug FDA: [Arcellx — Anito-cel regulatory designations](https://www.sec.gov/Archives/edgar/data/1786205/000119312522301426/d420020dex991.htm)

- Regenerative Medicine Advanced Therapy FDA: [Arcellx — Anito-cel regulatory designations](https://www.sec.gov/Archives/edgar/data/1786205/000119312522301426/d420020dex991.htm)

## Related Pages

- GILD PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/GILD.md

- GILD company profile: https://biopharmsignal.com/company/GILD.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md