Legend Biotech (LEGN) FDA Approvals

Legend Biotech's Drug in the FDA Approval Process

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 under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Poster Presentation - January 21,2026

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: January 21, 2026
• Indication: Relapsed and/or Refractory Multiple Myeloma

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.

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

updated results - December 7,2025

Phase 3

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: December 7, 2025
• Indication: Relapsed and/or Refractory Multiple Myeloma

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).

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.

Results - June 3,2025

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: June 3, 2025
• Indication: Relapsed and/or Refractory Multiple Myeloma

Legend Biotech Corporation announced new long-term results from the CARTITUDE-1 study in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients.

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.

Results - December 9,2024

Phase 3

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: December 9, 2024
• Indication: Relapsed and/or Refractory Multiple Myeloma

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

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.

Positive Results - July 2,2024

Phase 3

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: July 2, 2024
• Indication: Relapsed and/or Refractory Multiple Myeloma

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.

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.

Results - June 3,2024

Phase 2

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: June 3, 2024
• Indication: Relapsed and/or Refractory Multiple Myeloma

Legend Biotech Corporation announced today results for the first time from the Phase 2 CARTITUDE-2 Cohort D study in multiple myeloma patients.

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.

New Data - May 23,2024

• Drug: Ciltacabtagene Autoleucel (cilta-cel)
• Announced Date: May 23, 2024
• Indication: Relapsed and/or Refractory Multiple Myeloma

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.

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.