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STATUS · fda-aa-b7401160be177b705904

Amtagvi (lifileucel)

Open original source → · Download preserved record

This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

Source status category
ongoing
Event date
2024-02-16
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2024-02-16
accelerated approval date source text
2/16/2024
brand name hint
Amtagvi
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Amtagvi (lifileucel)
generic name hint
lifileucel
id
fda-aa-b7401160be177b705904
indication exact
Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
original projected completion source text
3/31/2031
post marketing requirement exact
1: Complete the Phase 3, multiregional, multicenter, randomized, open-label controlled trial (IOV-MEL-301) in patients with previously untreated unresectable or metastatic melanoma. Patients will be randomized to lifileucel (LN-144) regimen in combination with pembrolizumab or to pembrolizumab monotherapy. The dual primary endpoints will be ORR and PFS, with OS as the key secondary endpoint.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma
source cells exact
  1. links
      text
      Amtagvi (lifileucel)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma
      text
      Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
    2. links
        text
        2/16/2024
      1. links
          text
          1: Complete the Phase 3, multiregional, multicenter, randomized, open-label controlled trial (IOV-MEL-301) in patients with previously untreated unresectable or metastatic melanoma. Patients will be randomized to lifileucel (LN-144) regimen in combination with pembrolizumab or to pembrolizumab monotherapy. The dual primary endpoints will be ORR and PFS, with OS as the key secondary endpoint.
        1. links
            text
            3/31/2031
          source provenance
          bytes
          102185
          file
          /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
          http status
          200
          retrieved at
          2026-09-09T23:35:15.160724+00:00
          sha256
          8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
          source page date Modified text
          Wed, 09/09/2026 - 00:00
          source page date Published text
          Wed, 09/09/2026 - 12:45
          source row index
          27
          source table headers
          1. Drug Name
          2. Accelerated Approval (AA) Indication
          3. AA Date
          4. AA Post-Marketing Requirement
          5. Original Projected Completion 1
          source table index
          0
          source url
          https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
          status applies to
          This exact indication and regimen, not every use of this drug
          status category
          ongoing
          status event date
          2024-02-16
          status event date meaning
          Original accelerated approval date; ongoing status observed at source retrieval
          traditional approval date
          Source null
          verification flags
            verification status
            official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
            withdrawal date
            Source null
            Source correspondence records
            matching
            drug name exact
            Amtagvi (lifileucel)
            fda status record id
            fda-aa-b7401160be177b705904
            indication exact
            Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-0e9ae68d9d86abf6885d
            2. ind-span-71530f55fb26d7afc281
            source provenance
            bytes
            102185
            file
            /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
            http status
            200
            retrieved at
            2026-09-09T23:35:15.160724+00:00
            sha256
            8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
            source page date Modified text
            Wed, 09/09/2026 - 00:00
            source page date Published text
            Wed, 09/09/2026 - 12:45
            status category
            ongoing
            unmatched meaning
            Source null
            links
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-207a59c2c8490586a64410c3
              span id
              ind-span-71530f55fb26d7afc281
              status id
              fda-aa-b7401160be177b705904
              match method
              whole_indication_literal_normalized_substring
              scope relationship
              whole_fda_indication_text_present
              matching review status
              source_comparison_only_clinical_review_pending
              payload
              candidate source span
              end
              851
              end exclusive
              true
              exact text
              AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
              label id
              4120d6b2-93d7-e0bf-e063-6294a90a6e7f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              bbea6a5cfa504568eb2ee49396a5caba2f6e4f43dd750c55a1b4aa014df219f5
              start
              570
              fda indication exact
              Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
              fda source row index
              27
              fda source sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              fda status record id
              fda-aa-b7401160be177b705904
              interpretation
              Source wording correspondence to a dated FDA status row; current approval not certified
              match method
              whole_indication_literal_normalized_substring
              matching review status
              source_comparison_only_clinical_review_pending
              scope relationship
              whole_fda_indication_text_present
              status category
              ongoing
              status event date
              2024-02-16
              supporting anchor spans
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-9eb4d4c6b12746ecb036f690
                span id
                ind-span-0e9ae68d9d86abf6885d
                status id
                fda-aa-b7401160be177b705904
                match method
                whole_indication_literal_normalized_substring
                scope relationship
                whole_fda_indication_text_present
                matching review status
                source_comparison_only_clinical_review_pending
                payload
                candidate source span
                end
                305
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
                label id
                4120d6b2-93d7-e0bf-e063-6294a90a6e7f
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                bbea6a5cfa504568eb2ee49396a5caba2f6e4f43dd750c55a1b4aa014df219f5
                start
                0
                fda indication exact
                Adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
                fda source row index
                27
                fda source sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                fda status record id
                fda-aa-b7401160be177b705904
                interpretation
                Source wording correspondence to a dated FDA status row; current approval not certified
                match method
                whole_indication_literal_normalized_substring
                matching review status
                source_comparison_only_clinical_review_pending
                scope relationship
                whole_fda_indication_text_present
                status category
                ongoing
                status event date
                2024-02-16
                supporting anchor spans

                Preserved source evidence · Not medical advice