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
LB2501 and Ciltacabtagene. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LB2501 FDA Regulatory Events
LB2501 is a drug developed by Legend Biotech for the following indication: for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.
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:
- LB2501
- Announced Date:
- October 15, 2026
- Indication:
- for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.
Announcement
Legend Biotech Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LB2501, an investigational in vivo CAR-T therapy designed to generate CD19/CD20 dual-targeting chimeric antigen receptor T (CAR-T) cells directly within the patient, for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.
Read Announcement
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 under review 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:
- September 25, 2026
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced five-year follow-up data from CARTITUDE-2 Cohort A (n=20) evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in patients with relapsed/refractory multiple myeloma (RRMM) after one to three prior lines of therapy after a median follow-up of 60.7 months.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- September 10, 2026
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced that data from CARTITUDE-2 and real-world evidence will be presented at the 23rd International Myeloma Society (IMS) Annual Meeting, taking place September 23-26, 2026, in Glasgow, Scotland.
Read Announcement- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- January 21, 2026
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Legend Biotech Corporation announced that it will present six poster presentations featuring data on CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) at the Tandem Meetings of ASTCT® and CIBMTR®, taking place February 4-7, 2026, in Salt Lake City, UT.
AI Summary
Legend Biotech will present six poster presentations on CARVYKTI® (ciltacabtagene autoleucel) at the Tandem Meetings of ASTCT® and CIBMTR®, February 4–7, 2026, in Salt Lake City, UT. The company will share new clinical and real‑world data from CARTITUDE trials and related analyses.
The posters highlight consistent, durable efficacy and safety, real‑world outcomes from more than 10,000 patients treated worldwide, and meaningful quality‑adjusted survival gains tied to longer treatment‑free periods after a single CARVYKTI infusion. Data suggest outcomes are most favorable when the therapy is used earlier in the multiple myeloma treatment journey.
Specific poster topics include neurologic events and their management, the impact of bridging therapy and pre‑lymphodepletion tumor burden on outcomes, manufacturing outcomes by line of therapy, long‑term progression‑free survival in standard‑risk patients, and how effective bridging therapy improves post‑CARVYKTI results.
These presentations aim to inform clinicians on optimizing CARVYKTI use and refining patient selection to improve outcomes.Read Announcement
- Drug:
- Ciltacabtagene Autoleucel (cilta-cel)
- Announced Date:
- December 7, 2025
- Indication:
- Relapsed and/or Refractory Multiple Myeloma
Announcement
Johnson & Johnson announced updated results from the Phase 3 CARTITUDE-4 study supporting durable treatment-free remissions as early as second line treatment with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel).
AI Summary
Johnson & Johnson reported updated Phase 3 CARTITUDE-4 results showing that a single infusion of CARVYKTI® (ciltacabtagene autoleucel) can produce durable, treatment‑free remissions as early as second‑line therapy for relapsed or refractory multiple myeloma. In patients with standard‑risk cytogenetics treated as early as first relapse, about 80% of the as‑treated group remained progression‑ and treatment‑free at 30 months (median follow‑up 33.6 months).
In the analysis, 176 patients received CARVYKTI® as early as second line, including 59 with standard‑risk disease; the 30‑month progression‑free survival rate for that standard‑risk as‑treated group plateaued at 80.5% (95% CI, 67.2–88.8). Notably, all 26 patients who achieved MRD‑negative complete response at 12 months were still progression‑free at 30 months. Findings were presented at the 2025 ASH meeting.
Translational studies suggested stronger immune fitness when CARVYKTI® is used earlier—marked by higher baseline CD4+ naïve T cells and a more immune‑activated tumor microenvironment—which correlated with longer progression‑free survival and supports earlier use to achieve deeper, lasting remissions.
Read Announcement- 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
