Lifileucel History and Updates

33 events · 2015 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
33
Trial Milestones
0
Pivotal Publications
Lifileucel — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2015201620172018201920202021202220232024202520262027202820292030203120322033Trial: NCT07288203 2025-11-28 → 2032-12-31 (primary completion)Trial: NCT06743126 2025-01-14 → 2028-01-31 (primary completion)Trial: NCT06481592 2024-10-29 → 2028-05-31 (primary completion)Trial: NCT06151847 2023-12-21 → 2025-07-10 (primary completion)Trial: NCT05727904 2023-03-30 → 2028-03-01 (primary completion)Trial: NCT05640193 2022-11-25 → 2026-11-30 (primary completion)Trial: NCT05607095 2022-11-01 → 2027-05-01 (primary completion)Trial: NCT05176470 2022-07-01 → 2023-07-14 (primary completion)Trial: NCT03645928 2019-05-07 → 2029-08-09 (primary completion)Trial: NCT02360579 2015-09-24 → 2024-10-24 (primary completion)Results posted — 2025-12-09 Trial results posted: NCT02360579 Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanomatoday (2026-06-11)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Lifileucel since 2015, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05607095
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06743126
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05727904
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanom

Past events

2026
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05607095
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
2025
Results posted· ClinicalTrials.gov
Trial results posted: NCT02360579
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06151847
Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06743126
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06481592
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT02360579
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
2023
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06151847
Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05176470
Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05727904
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanom
2022
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05607095
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05176470
Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients
2019
2018
2015
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT02360579
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.