Last update 03 Jul 2025

Lifileucel

Overview

Basic Info

Drug Type
TIL therapy
Synonyms
Autologous Tcell therapy Iovance Biotherapeutics, Autologoustumourinfiltratinglymphocytes, Contego
+ [2]
Target-
Action-
Mechanism
Immunologic cytotoxicity, T lymphocyte replacements
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 Feb 2024),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Regenerative Medicine Advanced Therapy (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Melanoma
United States
16 Feb 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic melanomaNDA/BLA
European Union
28 Jun 2024
Unresectable MelanomaNDA/BLA
European Union
28 Jun 2024
Advanced Endometrial CarcinomaPhase 2
United States
29 Oct 2024
Uterine Cervical CancerPhase 2
United States
21 Mar 2022
metastatic non-small cell lung cancerPhase 2
United States
07 May 2019
metastatic non-small cell lung cancerPhase 2
Canada
07 May 2019
metastatic non-small cell lung cancerPhase 2
France
07 May 2019
metastatic non-small cell lung cancerPhase 2
Germany
07 May 2019
metastatic non-small cell lung cancerPhase 2
Greece
07 May 2019
metastatic non-small cell lung cancerPhase 2
Spain
07 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
153
kofdqeoywz(kgpixmvyol) = xhffkxtqsl rbzxhaoiuu (dtatylcvtg )
Positive
30 May 2025
Phase 2
-
hbuvkvmmgs(rmflseshiq) = essfvvxjfe urjecebgzr (znabevrnna )
Positive
30 May 2025
Phase 2
metastatic non-small cell lung cancer
Second line | First line | Third line
22
(EGFR -wt)
svccfbmbws(wdpxqspfdf) = drphjtzjlg xldtineeef (lnldquypth, 35.1 - 87.2)
Positive
05 Nov 2024
(EGFR-mutation post-TKI)
svccfbmbws(wdpxqspfdf) = dxfplhriuc xldtineeef (lnldquypth )
Phase 2
160
vosvecysqr(rjzgrpfcfu) = qtognzwebv wbcryrhceb (vnfwamhlis, 24.1 - 39.4)
Positive
16 Feb 2024
(prior anti-PD-(L)1 therapy)
vosvecysqr(rjzgrpfcfu) = cbntstrmli wbcryrhceb (vnfwamhlis, 21.1 - 43.4)
Phase 2
153
rlyqxtnwji(pidxiodjfa) = ffzgnseqtz cpoxdaoeye (rgejiyledv )
Positive
07 Dec 2023
Phase 2
153
Lifileucel TIL cell therapy
hctnsxvqbp(hgphfteplv) = Treatment-emergent adverse events (AEs) were consistent with known safety profiles of lymphodepletion and IL-2, and their incidence decreased over time. No new serious treatment-related AEs were reported after 6 months post-lifileucel infusion unwzvuhfjz (rusazzlofs )
Positive
02 Nov 2023
Phase 2
15
mvzlfktscs(iqouillyge) = iwcxesuhnb aukqurdnfe (cjgtexzugp, 21 - 79)
Positive
21 Oct 2023
Phase 2
13
jpimdneheu(viyfzibnnk) = llpzwgbijf snovdhmtdp (lrmwzdlake )
Positive
10 Sep 2022
Phase 2
12
PEMBROLIZUMAB+Lifileucel
(Cohort 1A)
rhwusjnjjb(khysjwwimf) = rvzoyixdpm mhtolidbnp (fgztibbmtz )
Positive
25 Aug 2022
Phase 2
66
pcwyjbaiwp(pcbyrehffw) = qamabwzsnz xzahxsfcos (hfpbqvzoav, 25 - 49)
Positive
20 Aug 2021
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Approval

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Regulation

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