FDA Events for Legend Biotech (LEGN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Legend Biotech (LEGN).
Over the past two years, Legend Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ciltacabtagene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ciltacabtagene Autoleucel (cilta-cel) - FDA Regulatory Timeline and Events
Ciltacabtagene Autoleucel (cilta-cel) is a drug developed by Legend Biotech for the following indication: Relapsed and/or Refractory Multiple Myeloma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- June 3, 2025
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced new long-term results from the CARTITUDE-1 study in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients.
AI Summary
Legend Biotech Corporation recently announced long-term results from the CARTITUDE-1 study in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). The study showed that after a single infusion of CARVYKTI®, about 33% of these patients remained progression-free for five years or more, without needing any additional myeloma treatment.
These remarkable outcomes were shared during an oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting. In a small group of patients who had regular minimal residual disease tests, all remained disease free and showed no signs of myeloma on their annual scans. The findings offer new hope for long-term disease control in patients with limited treatment options, highlighting CARVYKTI®’s potential to change current treatment strategies for RRMM.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- December 9, 2024
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Johnson & Johnson announced new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) significantly increased minimal residual disease (MRD) negativity rates (10-5) in patients with relapsed or refractory multiple myeloma (RRMM) who were lenalidomide-refractory and had received one to three prior lines of therapy, including a proteasome inhibitor (PI), compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1
AI Summary
Johnson & Johnson announced new Phase 3 CARTITUDE-4 results showing that a single infusion of CARVYKTI® (ciltacabtagene autoleucel) significantly increased minimal residual disease (MRD) negativity in patients with relapsed or refractory multiple myeloma. In the study, 89% of evaluable patients treated with CARVYKTI® reached MRD negativity (at a 10‑5 threshold), compared with only 38% in the standard therapy group. The majority of patients achieved MRD negativity in less than 2 months, reflecting a deep response to the treatment. These results add to the previously shared overall survival benefits, highlighting CARVYKTI® as the first and only cell therapy to significantly extend overall survival versus standard treatments for this patient population. The study included patients who were lenalidomide-refractory and who had received one to three prior lines of therapy, including a proteasome inhibitor.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- July 2, 2024
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Johnson & Johnson announced positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.
AI Summary
Johnson & Johnson announced positive outcomes from the second interim analysis of the Phase 3 CARTITUDE‑4 study. This trial compared CARVYKTI® (cilta‑cel), a BCMA‑targeted CAR‑T cell therapy, with standard treatments—either PVd (pomalidomide, bortezomib, and dexamethasone) or DPd (daratumumab, pomalidomide, and dexamethasone)—in patients with relapsed or lenalidomide‑refractory multiple myeloma after one prior line of therapy.
The study showed that patients receiving CARVYKTI® experienced statistically significant and clinically meaningful improvements in overall survival compared to those on standard therapies. CARVYKTI®, given as a one‑time infusion, marks a new approach by offering key survival benefits early in the treatment journey. These encouraging results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide for further evaluation.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- June 3, 2024
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced today results for the first time from the Phase 2 CARTITUDE-2 Cohort D study in multiple myeloma patients.
AI Summary
Legend Biotech Corporation announced new Phase 2 study results from CARTITUDE-2 Cohort D, focusing on multiple myeloma patients who did not achieve a complete response after a front‐line autologous stem cell transplant. These patients received a one-time infusion of CARVYKTI®, with or without lenalidomide maintenance therapy, and the findings were shared at the 2024 ASCO Annual Meeting. The study reported a high overall response rate of 94%, with all responding patients reaching complete response or better. In addition, 80% of the evaluable patients achieved minimal residual disease negativity at a stringent threshold. With a median follow-up of 22 months, the responses appeared both deep and durable, and the 18‐month progression-free and overall survival rates were 94% each. The safety profile was consistent with previous reports, underscoring the potential benefit of CARVYKTI® in this patient group.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- May 23, 2024
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced that new and updated data from the CARTITUDE clinical development program evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for patients with multiple myeloma will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2024 European Hematology Association's (EHA) Hybrid Congress.
AI Summary
Legend Biotech Corporation announced that new and updated data from the CARTITUDE clinical development program will be presented at two major 2024 conferences. The company will share results from studies of CARVYKTI® (ciltacabtagene autoleucel) in patients with multiple myeloma. Specifically, data from the Phase 2 CARTITUDE-2 study, which evaluates a single infusion of CARVYKTI® in patients with less than a complete response after front-line autologous stem cell transplant, will be featured in an oral presentation at the 2024 ASCO Annual Meeting. Additionally, updated subgroup analyses from the Phase 3 CARTITUDE-4 study, including insights on patients with high-risk features and cytogenetic risk, will also be presented at the 2024 European Hematology Association Hybrid Congress.
The findings are expected to offer valuable information on the safety and efficacy of CARVYKTI®, potentially providing new hope for patients with multiple myeloma.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- April 22, 2024
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced that that the European Commission (EC) has granted approval of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
AI Summary
Legend Biotech Corporation announced that the European Commission has approved CARVYKTI® (ciltacabtagene autoleucel) for adult patients with relapsed and refractory multiple myeloma. Approved patients must have received at least one prior therapy that included a proteasome inhibitor and an immunomodulatory agent, have experienced disease progression on their last treatment, and be refractory to lenalidomide.
This decision, based on the positive findings from the ongoing CARTITUDE-4 study, showed that CARVYKTI® significantly improved progression-free survival compared to standard treatment regimens. The new indication may provide patients with a treatment-free respite from their illness, potentially changing the approach to treating this incurable disease and offering new hope to patients battling multiple myeloma.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- April 5, 2024
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.
AI Summary
Legend Biotech Corporation has received FDA approval for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) to treat patients with relapsed or refractory multiple myeloma. The treatment is approved for those who have already received at least one prior therapy—including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD)—and are refractory to lenalidomide. This expands the treatment options for patients whose disease has returned or is resistant to earlier treatments. CARVYKTI® is a first-in-class therapy targeting B-cell Maturation Antigen (BCMA), offering a personalized immunotherapy that can be administered as early as first relapse. The decision was supported by positive results from the CARTITUDE-4 study, which demonstrated statistically significant improvements in progression-free survival compared to standard treatment regimens.
Read Announcement
Legend Biotech FDA Events - Frequently Asked Questions
Yes, Legend Biotech (LEGN) has received FDA approval for Ciltacabtagene Autoleucel (cilta-cel). This page tracks recent and historical FDA regulatory events related to Legend Biotech's drug portfolio.
In the past two years, Legend Biotech (LEGN) has reported FDA regulatory activity for Ciltacabtagene Autoleucel (cilta-cel).
The most recent FDA-related event for Legend Biotech occurred on June 3, 2025, involving Ciltacabtagene Autoleucel (cilta-cel). The update was categorized as "Results," with the company reporting: "Legend Biotech Corporation announced new long-term results from the CARTITUDE-1 study in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients."
Currently, Legend Biotech has one therapy (Ciltacabtagene Autoleucel (cilta-cel)) targeting the following condition: Relapsed and/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:LEGN) was last updated on 7/12/2025 by MarketBeat.com Staff
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