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LABELS · 8731b3b1-29d9-46b1-a443-822d8057f773

Torisel

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
2025-12-26
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
Full extracted label fields
application numbers
  1. NDA022088
boxed warning exact
    brand names
    1. Torisel
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=95b7dc92-2180-42f1-8699-3c28f609e674
    generic names
    1. TEMSIROLIMUS
    id
    8731b3b1-29d9-46b1-a443-822d8057f773
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 0008-1179-01
      2. 0008-1279-01
      3. 0008-1125-01
      product ndcs
      1. 0008-1179
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
          rxcuis
          1. 722289
          2. 725108
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00500.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
          500
          total
          830
          sha256
          424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
          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=500&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%228731b3b1-29d9-46b1-a443-822d8057f773%22
          spl effective date
          2025-12-26
          spl effective time
          20251226
          spl set id
          95b7dc92-2180-42f1-8699-3c28f609e674
          spl version
          39
          substance names
            uniis
              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
              Drugs@FDA application source records
              1. application number
                NDA022088
                payload
                all indexed label documents
                1. Appl No
                  022088
                  Application Docs Date
                  2007-06-04 00:00:00
                  Application Docs ID
                  16920
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  1
                  Submission Type
                  ORIG
                2. Appl No
                  022088
                  Application Docs Date
                  2007-11-19 00:00:00
                  Application Docs ID
                  16921
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  1
                  Submission Type
                  SUPPL
                3. Appl No
                  022088
                  Application Docs Date
                  2010-04-28 00:00:00
                  Application Docs ID
                  16922
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  6
                  Submission Type
                  SUPPL
                4. Appl No
                  022088
                  Application Docs Date
                  2010-07-12 00:00:00
                  Application Docs ID
                  16923
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  8
                  Submission Type
                  SUPPL
                5. Appl No
                  022088
                  Application Docs Date
                  2014-10-09 00:00:00
                  Application Docs ID
                  16924
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  17
                  Submission Type
                  SUPPL
                6. Appl No
                  022088
                  Application Docs Date
                  2015-03-02 00:00:00
                  Application Docs ID
                  16925
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  18
                  Submission Type
                  SUPPL
                7. Appl No
                  022088
                  Application Docs Date
                  2016-07-28 00:00:00
                  Application Docs ID
                  16926
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  19
                  Submission Type
                  SUPPL
                8. Appl No
                  022088
                  Application Docs Date
                  2011-06-16 00:00:00
                  Application Docs ID
                  38208
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  2
                  Submission Type
                  SUPPL
                9. Appl No
                  022088
                  Application Docs Date
                  2011-06-16 00:00:00
                  Application Docs ID
                  38209
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  4
                  Submission Type
                  SUPPL
                10. Appl No
                  022088
                  Application Docs Date
                  2011-06-16 00:00:00
                  Application Docs ID
                  38210
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  5
                  Submission Type
                  SUPPL
                11. Appl No
                  022088
                  Application Docs Date
                  2011-06-16 00:00:00
                  Application Docs ID
                  38211
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  7
                  Submission Type
                  SUPPL
                12. Appl No
                  022088
                  Application Docs Date
                  2011-06-16 00:00:00
                  Application Docs ID
                  38212
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  10
                  Submission Type
                  SUPPL
                all submission records
                1. Appl No
                  022088
                  Review Priority
                  PRIORITY
                  Submission Class Code ID
                  7
                  Submission No
                  1
                  Submission Status
                  AP
                  Submission Status Date
                  2007-05-30 00:00:00
                  Submission Type
                  ORIG
                  Submissions Public Notes
                2. Appl No
                  022088
                  Review Priority
                  PRIORITY
                  Submission Class Code ID
                  4
                  Submission No
                  1
                  Submission Status
                  AP
                  Submission Status Date
                  2007-11-09 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                3. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  2
                  Submission Status
                  AP
                  Submission Status Date
                  2011-06-16 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                4. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  4
                  Submission Status
                  AP
                  Submission Status Date
                  2011-06-16 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                5. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  5
                  Submission Status
                  AP
                  Submission Status Date
                  2011-06-16 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                6. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  2
                  Submission No
                  6
                  Submission Status
                  AP
                  Submission Status Date
                  2010-04-26 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                7. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  3
                  Submission No
                  7
                  Submission Status
                  AP
                  Submission Status Date
                  2011-06-16 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                8. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  2
                  Submission No
                  8
                  Submission Status
                  AP
                  Submission Status Date
                  2010-07-09 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                9. Appl No
                  022088
                  Review Priority
                  UNKNOWN
                  Submission Class Code ID
                  3
                  Submission No
                  10
                  Submission Status
                  AP
                  Submission Status Date
                  2011-06-16 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                10. Appl No
                  022088
                  Review Priority
                  UNKNOWN
                  Submission Class Code ID
                  3
                  Submission No
                  12
                  Submission Status
                  AP
                  Submission Status Date
                  2011-06-16 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                11. Appl No
                  022088
                  Review Priority
                  STANDARD
                  Submission Class Code ID
                  2
                  Submission No
                  14
                  Submission Status
                  AP
                  Submission Status Date
                  2012-05-30 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                12. Appl No
                  022088
                  Review Priority
                  PRIORITY
                  Submission Class Code ID
                  4
                  Submission No
                  15
                  Submission Status
                  AP
                  Submission Status Date
                  2013-12-20 00:00:00
                  Submission Type
                  SUPPL
                  Submissions Public Notes
                application number
                NDA022088
                approval interpretation
                Application linkage and approved submission are not indication-level current approval verification
                current indication status
                not_reconciled
                has approved submission record
                true
                latest approved submission date
                2018-03-23
                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
                1. Appl No
                  022088
                  Application Docs Date
                  2018-03-27 00:00:00
                  Application Docs ID
                  53465
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  21
                  Submission Type
                  SUPPL
                2. Appl No
                  022088
                  Application Docs Date
                  2018-03-27 00:00:00
                  Application Docs ID
                  53466
                  Application Docs Title
                  0
                  Application Docs Type ID
                  2
                  Submission No
                  23
                  Submission Type
                  SUPPL
                official application record
                Appl No
                022088
                Appl Public Notes
                Appl Type
                NDA
                Sponsor Name
                PF PRISM CV
                openfda application present
                true
                products
                1. Active Ingredient
                  TEMSIROLIMUS
                  Appl No
                  022088
                  Drug Name
                  TORISEL
                  Form
                  SOLUTION;INTRAVENOUS
                  Product No
                  001
                  Reference Drug
                  1
                  Reference Standard
                  1
                  Strength
                  25MG/ML (25MG/ML)
                  marketing status
                  1. Prescription

              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. NDA022088
              brand names
              1. Torisel
              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
              196
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
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              source text sha256
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              duplicate text group
              dup-c574473fab1baa3d648d
              extraction review status
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              generic names
              1. TEMSIROLIMUS
              id
              ind-span-5303d366b10d960dcbd4
              label id
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              positive predicate support span
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              44
              end exclusive
              true
              exact text
              is indicated
              label id
              8731b3b1-29d9-46b1-a443-822d8057f773
              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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              start
              32
              qualifier mentions
              1. context exact
                CATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma.
                kind
                stage_or_setting
                polarity
                not_inferred
                span
                end
                95
                end exclusive
                true
                exact text
                advanced renal cell carcinoma
                label id
                8731b3b1-29d9-46b1-a443-822d8057f773
                offset unit
                unicode_code_points
                source array index
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                source field
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                source text sha256
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                start
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              regulatory links
                schema version
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                source batch sha256
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                source defined aliases
                  source span
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                  96
                  end exclusive
                  true
                  exact text
                  1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma.
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                  source url
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                  spl effective date
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                  spl set id
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                  spl version
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                  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 · positive indication candidate
                  application numbers
                  1. NDA022088
                  brand names
                  1. Torisel
                  classification reasons
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                  2. tumor_or_malignant_hematology_words_in_positive_statement
                  clinical review status
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                  196
                  end exclusive
                  true
                  exact text
                  1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
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                  label id
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                  positive predicate support span
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                  end exclusive
                  true
                  exact text
                  is a kinase inhibitor indicated
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                  qualifier mentions
                  1. context exact
                    ISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
                    kind
                    stage_or_setting
                    polarity
                    not_inferred
                    span
                    end
                    189
                    end exclusive
                    true
                    exact text
                    advanced renal cell carcinoma
                    label id
                    8731b3b1-29d9-46b1-a443-822d8057f773
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                  regulatory links
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                      true
                      exact text
                      TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
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                      source url
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                      spl effective date
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                      spl set id
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                      spl version
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                      structured fields status
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                      structured indication
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                      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 3 · unclassified context
                      application numbers
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                      exact text
                      1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )
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                      positive predicate support span
                      Source null
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                            end exclusive
                            true
                            exact text
                            ( 1 )
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                            offset unit
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                            source text sha256
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                            start
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                            source url
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                            spl effective date
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                            spl set id
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                            spl version
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                            structured fields status
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                            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