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LABELS · b4a9e0a0-a882-485b-918f-7134992246ce

PIQRAY

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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
2025-12-15
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Full extracted label fields
application numbers
  1. NDA212526
boxed warning exact
    brand names
    1. PIQRAY
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b20b4e18-7a4b-4500-a08f-06c6dab0ee5b
    generic names
    1. ALPELISIB
    id
    b4a9e0a0-a882-485b-918f-7134992246ce
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Novartis Pharmaceuticals Corporation
      matched search terms
      1. cancer
      package ndcs
      1. 0078-0708-51
      2. 0078-0708-02
      3. 0078-0708-90
      4. 0078-0708-91
      5. 0078-0715-61
      6. 0078-0715-02
      7. 0078-0715-94
      8. 0078-0715-91
      9. 0078-0701-51
      10. 0078-0701-84
      product ndcs
      1. 0078-0701
      2. 0078-0708
      3. 0078-0715
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 1/2024 Dosage and Administration, Dose Modifications for Adverse Reactions ( 2.3 ) 1/2024 Warnings and Precautions, Hyperglycemia ( 5.3 ) 1/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2169300
      2. 2169307
      3. 2169310
      4. 2169311
      5. 2169313
      6. 2169314
      7. 2169316
      8. 2169318
      9. 2169319
      10. 2169320
      11. 2169321
      12. 2169322
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.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
      600
      total
      830
      sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      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=600&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22b4a9e0a0-a882-485b-918f-7134992246ce%22
      spl effective date
      2025-12-15
      spl effective time
      20251215
      spl set id
      b20b4e18-7a4b-4500-a08f-06c6dab0ee5b
      spl version
      13
      substance names
      1. ALPELISIB
      uniis
      1. 08W5N2C97Q
      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
        NDA212526
        payload
        all indexed label documents
        1. Appl No
          212526
          Application Docs Date
          2019-05-24 00:00:00
          Application Docs ID
          58863
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          212526
          Application Docs Date
          2020-09-04 00:00:00
          Application Docs ID
          64497
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          212526
          Application Docs Date
          2021-07-21 00:00:00
          Application Docs ID
          68152
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          212526
          Application Docs Date
          2022-05-06 00:00:00
          Application Docs ID
          71018
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        5. Appl No
          212526
          Application Docs Date
          2022-11-23 00:00:00
          Application Docs ID
          72680
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        6. Appl No
          212526
          Application Docs Date
          2024-01-19 00:00:00
          Application Docs ID
          77246
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          212526
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2024-01-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          212526
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2022-11-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          212526
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2022-05-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          212526
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2021-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          212526
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-09-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          212526
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-05-24 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA212526
        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
        2024-01-18
        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
          212526
          Application Docs Date
          2024-01-19 00:00:00
          Application Docs ID
          77246
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        official application record
        Appl No
        212526
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          ALPELISIB
          Appl No
          212526
          Drug Name
          PIQRAY
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Prescription
        2. Active Ingredient
          ALPELISIB
          Appl No
          212526
          Drug Name
          PIQRAY
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          150MG
          marketing status
          1. Prescription
        3. Active Ingredient
          ALPELISIB
          Appl No
          212526
          Drug Name
          PIQRAY
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          200MG
          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. NDA212526
      brand names
      1. PIQRAY
      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
      549
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3C
      label id
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      source text sha256
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      current approval status
      not_reconciled
      duplicate text group
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      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ALPELISIB
      id
      ind-span-5e75b57dc2217484ff67
      label id
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      positive predicate support span
      end
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      end exclusive
      true
      exact text
      is indicated
      label id
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      source text sha256
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      qualifier mentions
      1. context exact
        icated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth
        kind
        age
        polarity
        not_inferred
        span
        end
        103
        end exclusive
        true
        exact text
        adults
        label id
        b4a9e0a0-a882-485b-918f-7134992246ce
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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      2. context exact
        or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as de
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        197
        end exclusive
        true
        exact text
        HER2)-negative
        label id
        b4a9e0a0-a882-485b-918f-7134992246ce
        offset unit
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        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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      3. context exact
        , human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        213
        end exclusive
        true
        exact text
        PIK3CA-mutated
        label id
        b4a9e0a0-a882-485b-918f-7134992246ce
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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      4. context exact
        tor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endoc
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        270
        end exclusive
        true
        exact text
        metastatic breast cancer as detected by an
        label id
        b4a9e0a0-a882-485b-918f-7134992246ce
        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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      5. context exact
        l growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or af
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        258
        end exclusive
        true
        exact text
        advanced or metastatic breast cancer as det
        label id
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        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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      6. context exact
        1 INDICATIONS AND USAGE PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved
        kind
        regimen
        polarity
        not_inferred
        span
        end
        223
        end exclusive
        true
        exact text
        in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced
        label id
        b4a9e0a0-a882-485b-918f-7134992246ce
        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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      regulatory links
        schema version
        0.1.0
        source batch sha256
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        source defined aliases
          source span
          end
          349
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
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          source text sha256
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22b4a9e0a0-a882-485b-918f-7134992246ce%22
          spl effective date
          2025-12-15
          spl set id
          b20b4e18-7a4b-4500-a08f-06c6dab0ee5b
          spl version
          13
          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. NDA212526
          brand names
          1. PIQRAY
          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
          694
          end exclusive
          true
          exact text
          dermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
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          current approval status
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          generic names
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          id
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          label id
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          true
          exact text
          is a kinase inhibitor indicated
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          qualifier mentions
          1. context exact
            icated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth
            kind
            age
            polarity
            not_inferred
            span
            end
            448
            end exclusive
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            exact text
            adults
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          2. context exact
            or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as de
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            542
            end exclusive
            true
            exact text
            HER2)-negative
            label id
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            offset unit
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            source field
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            source text sha256
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            start
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          3. context exact
            , human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            558
            end exclusive
            true
            exact text
            PIK3CA-mutated
            label id
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            offset unit
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            source array index
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            source field
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            source text sha256
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          4. context exact
            tor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endoc
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            615
            end exclusive
            true
            exact text
            metastatic breast cancer as detected by an
            label id
            b4a9e0a0-a882-485b-918f-7134992246ce
            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
            572
          5. context exact
            l growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or af
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            603
            end exclusive
            true
            exact text
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              Preserved source evidence · Not medical advice