Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 4d1843a8-7a83-4062-ba8c-4f97e2f1427b

Imlygic

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-04-04
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
Full extracted label fields
application numbers
  1. BLA125518
boxed warning exact
    brand names
    1. Imlygic
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
    generic names
    1. TALIMOGENE LAHERPAREPVEC
    id
    4d1843a8-7a83-4062-ba8c-4f97e2f1427b
    indications and usage exact
    1. 1 INDICATIONS AND USAGE IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amgen Inc
      matched search terms
      1. melanoma
      package ndcs
      1. 55513-078-01
      2. 55513-079-01
      product ndcs
      1. 55513-078
      2. 55513-079
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.2 ) 2/2023 Warnings and Precautions ( 5.7 ) 6/2022
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRALESIONAL
      rxcuis
      1. 1721278
      2. 1721283
      3. 1721287
      4. 1721289
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00300.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      300
      total
      830
      sha256
      bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%224d1843a8-7a83-4062-ba8c-4f97e2f1427b%22
      spl effective date
      2025-04-04
      spl effective time
      20250404
      spl set id
      64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
      spl version
      27
      substance names
      1. TALIMOGENE LAHERPAREPVEC
      uniis
      1. 07730V90L6
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      4. no_matched_approved_submission
      5. application_missing_from_drugsfda_bulk
      Drugs@FDA application source records
      1. application number
        BLA125518
        payload
        all indexed label documents
          all submission records
            application number
            BLA125518
            approval interpretation
            Application linkage and approved submission are not indication-level current approval verification
            current indication status
            not_reconciled
            has approved submission record
            false
            latest approved submission date
            Source null
            latest label selection rule
            max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
            latest posted label documents
              official application record
              Source null
              openfda application present
              false
              products

              Source passages and status connections

              Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

              Passage 1 · positive indication candidate
              application numbers
              1. BLA125518
              brand names
              1. Imlygic
              classification reasons
              1. explicit_positive_indication_predicate
              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              433
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local
              label id
              4d1843a8-7a83-4062-ba8c-4f97e2f1427b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
              start
              0
              current approval status
              not_reconciled
              duplicate text group
              dup-4a0a751fc8476ff2c47f
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. TALIMOGENE LAHERPAREPVEC
              id
              ind-span-0d3bcb30280edd7fcba1
              label id
              4d1843a8-7a83-4062-ba8c-4f97e2f1427b
              positive predicate support span
              end
              91
              end exclusive
              true
              exact text
              is a genetically modified oncolytic viral therapy indicated
              label id
              4d1843a8-7a83-4062-ba8c-4f97e2f1427b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
              start
              32
              qualifier mentions
              1. context exact
                ncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma
                kind
                stage_or_setting
                polarity
                not_inferred
                span
                end
                141
                end exclusive
                true
                exact text
                unresectable cutaneous
                label id
                4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                start
                119
              2. context exact
                , subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
                kind
                stage_or_setting
                polarity
                not_inferred
                span
                end
                232
                end exclusive
                true
                exact text
                recurrent after initial surgery
                label id
                4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                start
                201
              regulatory links
                schema version
                0.1.0
                source batch sha256
                bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                source defined aliases
                  source span
                  end
                  233
                  end exclusive
                  true
                  exact text
                  1 INDICATIONS AND USAGE IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
                  label id
                  4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                  start
                  0
                  source url
                  https://api.fda.gov/drug/label.json?search=id%3A%224d1843a8-7a83-4062-ba8c-4f97e2f1427b%22
                  spl effective date
                  2025-04-04
                  spl set id
                  64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
                  spl version
                  27
                  structured fields status
                  not_extracted_no_values_inferred_from_mentions
                  structured indication
                  age
                  Source null
                  approval pathway
                  Source null
                  biomarker and test
                  Source null
                  disease stage
                  Source null
                  limitations
                  Source null
                  line
                  Source null
                  prior therapy
                  Source null
                  regimen
                  Source null
                  tumor histology
                  Source null
                  use intent
                  tumor_directed_candidate
                  Passage 2 · unclassified context
                  application numbers
                  1. BLA125518
                  brand names
                  1. Imlygic
                  classification reasons
                  1. no_unambiguous_positive_indication_predicate
                  clinical review status
                  pending
                  content role
                  unclassified_context
                  context span
                  end
                  551
                  end exclusive
                  true
                  exact text
                  a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initia
                  label id
                  4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                  start
                  34
                  current approval status
                  not_reconciled
                  duplicate text group
                  dup-9ae5fd05a645a5106cc3
                  extraction review status
                  automated_candidate_pending_source_review
                  generic names
                  1. TALIMOGENE LAHERPAREPVEC
                  id
                  ind-span-5b890ad22fabc3856cd8
                  label id
                  4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                  positive predicate support span
                  Source null
                  qualifier mentions
                  1. context exact
                    n to improve overall survival or have an effect on visceral metastases.
                    kind
                    biomarker
                    polarity
                    not_inferred
                    span
                    end
                    350
                    end exclusive
                    true
                    exact text
                    metastases
                    label id
                    4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                    start
                    340
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                    source defined aliases
                      source span
                      end
                      351
                      end exclusive
                      true
                      exact text
                      Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.
                      label id
                      4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                      start
                      234
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%224d1843a8-7a83-4062-ba8c-4f97e2f1427b%22
                      spl effective date
                      2025-04-04
                      spl set id
                      64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
                      spl version
                      27
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      unclear
                      Passage 3 · positive indication candidate
                      application numbers
                      1. BLA125518
                      brand names
                      1. Imlygic
                      classification reasons
                      1. explicit_positive_indication_predicate
                      2. tumor_or_malignant_hematology_words_in_positive_statement
                      clinical review status
                      pending
                      content role
                      positive_indication_candidate
                      context span
                      end
                      685
                      end exclusive
                      true
                      exact text
                      ous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
                      label id
                      4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                      start
                      152
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-298c988da761ccbebc75
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. TALIMOGENE LAHERPAREPVEC
                      id
                      ind-span-c9cff0a917b1a02d0b44
                      label id
                      4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                      positive predicate support span
                      end
                      419
                      end exclusive
                      true
                      exact text
                      is a genetically modified oncolytic viral therapy indicated
                      label id
                      4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                      start
                      360
                      qualifier mentions
                      1. context exact
                        ncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma
                        kind
                        stage_or_setting
                        polarity
                        not_inferred
                        span
                        end
                        469
                        end exclusive
                        true
                        exact text
                        unresectable cutaneous
                        label id
                        4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                        start
                        447
                      2. context exact
                        , subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
                        kind
                        stage_or_setting
                        polarity
                        not_inferred
                        span
                        end
                        560
                        end exclusive
                        true
                        exact text
                        recurrent after initial surgery
                        label id
                        4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                        start
                        529
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                        source defined aliases
                          source span
                          end
                          561
                          end exclusive
                          true
                          exact text
                          IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
                          label id
                          4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                          start
                          352
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%224d1843a8-7a83-4062-ba8c-4f97e2f1427b%22
                          spl effective date
                          2025-04-04
                          spl set id
                          64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
                          spl version
                          27
                          structured fields status
                          not_extracted_no_values_inferred_from_mentions
                          structured indication
                          age
                          Source null
                          approval pathway
                          Source null
                          biomarker and test
                          Source null
                          disease stage
                          Source null
                          limitations
                          Source null
                          line
                          Source null
                          prior therapy
                          Source null
                          regimen
                          Source null
                          tumor histology
                          Source null
                          use intent
                          tumor_directed_candidate
                          Passage 4 · unclassified context
                          application numbers
                          1. BLA125518
                          brand names
                          1. Imlygic
                          classification reasons
                          1. no_unambiguous_positive_indication_predicate
                          clinical review status
                          pending
                          content role
                          unclassified_context
                          context span
                          end
                          685
                          end exclusive
                          true
                          exact text
                          a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
                          label id
                          4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                          start
                          362
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-9ae5fd05a645a5106cc3
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. TALIMOGENE LAHERPAREPVEC
                          id
                          ind-span-66ffaa722816af037918
                          label id
                          4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                          positive predicate support span
                          Source null
                          qualifier mentions
                          1. context exact
                            n to improve overall survival or have an effect on visceral metastases.
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            678
                            end exclusive
                            true
                            exact text
                            metastases
                            label id
                            4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                            start
                            668
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                            source defined aliases
                              source span
                              end
                              679
                              end exclusive
                              true
                              exact text
                              Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.
                              label id
                              4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                              start
                              562
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%224d1843a8-7a83-4062-ba8c-4f97e2f1427b%22
                              spl effective date
                              2025-04-04
                              spl set id
                              64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
                              spl version
                              27
                              structured fields status
                              not_extracted_no_values_inferred_from_mentions
                              structured indication
                              age
                              Source null
                              approval pathway
                              Source null
                              biomarker and test
                              Source null
                              disease stage
                              Source null
                              limitations
                              Source null
                              line
                              Source null
                              prior therapy
                              Source null
                              regimen
                              Source null
                              tumor histology
                              Source null
                              use intent
                              unclear
                              Passage 5 · unclassified context
                              application numbers
                              1. BLA125518
                              brand names
                              1. Imlygic
                              classification reasons
                              1. no_unambiguous_positive_indication_predicate
                              clinical review status
                              pending
                              content role
                              unclassified_context
                              context span
                              end
                              685
                              end exclusive
                              true
                              exact text
                              ous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
                              label id
                              4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                              start
                              480
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-e5cb32972d0ab7ef7f45
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. TALIMOGENE LAHERPAREPVEC
                              id
                              ind-span-c50f0dee8dc44e96f128
                              label id
                              4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                              positive predicate support span
                              Source null
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                                  source defined aliases
                                    source span
                                    end
                                    685
                                    end exclusive
                                    true
                                    exact text
                                    ( 1 )
                                    label id
                                    4d1843a8-7a83-4062-ba8c-4f97e2f1427b
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    c850b18dd97b813f3d13538071a89089c641c21ac0418fdcede50d79f0054209
                                    start
                                    680
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%224d1843a8-7a83-4062-ba8c-4f97e2f1427b%22
                                    spl effective date
                                    2025-04-04
                                    spl set id
                                    64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
                                    spl version
                                    27
                                    structured fields status
                                    not_extracted_no_values_inferred_from_mentions
                                    structured indication
                                    age
                                    Source null
                                    approval pathway
                                    Source null
                                    biomarker and test
                                    Source null
                                    disease stage
                                    Source null
                                    limitations
                                    Source null
                                    line
                                    Source null
                                    prior therapy
                                    Source null
                                    regimen
                                    Source null
                                    tumor histology
                                    Source null
                                    use intent
                                    unclear

                                    Preserved source evidence · Not medical advice