Arcellx's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Arcellx (ACLX).
Over the past two years, Arcellx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
anitocabtagene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Anitocabtagene autoleucel FDA Regulatory Events
Anitocabtagene autoleucel is a drug developed by Arcellx for the following indication: In patients with relapsed or refractory multiple myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- anitocabtagene autoleucel
- Announced Date:
- May 14, 2025
- Indication:
- In patients with relapsed or refractory multiple myeloma
Announcement
Arcellx, Inc announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM).
AI Summary
Arcellx, Inc. announced positive new results from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma. In the study, all 117 patients treated showed promising outcomes with a 97% overall response rate and a 68% complete or stringent complete response rate at a median follow-up of 12.6 months. This indicates a strong effect of anito-cel in heavily pre-treated patients, including those with triple- and penta-refractory disease.
Importantly, the study demonstrated a favorable safety profile. No delayed neurotoxicities—such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—and no immune-mediated enterocolitis were reported. These encouraging results support anito-cel’s potential as an effective and safe treatment option for multiple myeloma patients, with detailed data to be presented at the EHA2025 Congress in Milan.
Read Announcement- Drug:
- anitocabtagene autoleucel
- Announced Date:
- December 8, 2024
- Indication:
- In patients with relapsed or refractory multiple myeloma
Announcement
Arcellx, Inc announced new positive data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM).
AI Summary
Arcellx, Inc. announced positive results from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in relapsed or refractory multiple myeloma (RRMM) patients. Among 86 efficacy evaluable patients, the study reported a 97% overall response rate, including a 62% complete/stringent complete response rate at a median follow-up of 9.5 months. These promising outcomes suggest that anito-cel may provide deep and durable responses for patients who have received multiple prior treatments. Furthermore, the safety profile remains manageable, as no delayed neurotoxicities—such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—have been observed in over 150 patients treated to date. The new data will be highlighted at the upcoming American Society of Hematology Annual Meeting, showcasing anito-cel’s potential as a best-in-class CAR T-cell therapy for RRMM.Read Announcement
Arcellx FDA Events - Frequently Asked Questions
As of now, Arcellx (ACLX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Arcellx (ACLX) has reported FDA regulatory activity for anitocabtagene autoleucel.
The most recent FDA-related event for Arcellx occurred on May 14, 2025, involving anitocabtagene autoleucel. The update was categorized as "Positive Data," with the company reporting: "Arcellx, Inc announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM)."
Currently, Arcellx has one therapy (anitocabtagene autoleucel) targeting the following condition: In patients with relapsed or refractory multiple myeloma.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ACLX) was last updated on 7/17/2025 by MarketBeat.com Staff
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