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LABELS · dd6ab36d-21fa-4513-a9d1-0867ca4420e8

Itovebi

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
2026-04-21
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 )
Full extracted label fields
application numbers
  1. NDA219249
boxed warning exact
    brand names
    1. Itovebi
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5de59f5b-e5db-410f-b692-658686ef4107
    generic names
    1. INAVOLISIB
    id
    dd6ab36d-21fa-4513-a9d1-0867ca4420e8
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Genentech, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 50242-079-08
      2. 50242-079-86
      3. 50242-084-08
      product ndcs
      1. 50242-079
      2. 50242-084
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Hyperglycemia ( 5.1 ) 09/2025 Dosage and Administration, Recommended Dosage in Patients with Moderate or Severe Renal Impairment ( 2.5 ) 04/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2695427
      2. 2695433
      3. 2695435
      4. 2695437
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.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
      700
      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22dd6ab36d-21fa-4513-a9d1-0867ca4420e8%22
      spl effective date
      2026-04-21
      spl effective time
      20260421
      spl set id
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      spl version
      10
      substance names
      1. INAVOLISIB
      uniis
      1. L4C1UY2NYH
      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
        NDA219249
        payload
        all indexed label documents
        1. Appl No
          219249
          Application Docs Date
          2024-10-11 00:00:00
          Application Docs ID
          79857
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          219249
          Application Docs Date
          2025-09-25 00:00:00
          Application Docs ID
          83559
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          219249
          Application Docs Date
          2026-04-17 00:00:00
          Application Docs ID
          85705
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          219249
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-10-10 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          219249
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2025-09-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          219249
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2026-04-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA219249
        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
        2026-04-15
        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
          219249
          Application Docs Date
          2026-04-17 00:00:00
          Application Docs ID
          85705
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        official application record
        Appl No
        219249
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        GENENTECH INC
        openfda application present
        true
        products
        1. Active Ingredient
          INAVOLISIB
          Appl No
          219249
          Drug Name
          ITOVEBI
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          3MG
          marketing status
          1. Prescription
        2. Active Ingredient
          INAVOLISIB
          Appl No
          219249
          Drug Name
          ITOVEBI
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          9MG
          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. NDA219249
      brand names
      1. Itovebi
      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
      642
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human ep
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      duplicate text group
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      generic names
      1. INAVOLISIB
      id
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      label id
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      qualifier mentions
      1. context exact
        bociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor
        kind
        age
        polarity
        not_inferred
        span
        end
        122
        end exclusive
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        exact text
        adults
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      2. context exact
        cated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth fac
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        164
        end exclusive
        true
        exact text
        PIK3CA -mutated
        label id
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      3. context exact
        or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected
        kind
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        not_inferred
        span
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        end exclusive
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        exact text
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      4. context exact
        owth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        300
        end exclusive
        true
        exact text
        metastatic breast cancer
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      5. context exact
        , human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence
        kind
        stage_or_setting
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        not_inferred
        span
        end
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        end exclusive
        true
        exact text
        locally advanced or metastatic breast cancer
        label id
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      6. context exact
        -approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] .
        kind
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        not_inferred
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        426
        end exclusive
        true
        exact text
        adjuvant endocrine therapy [see Clinical St
        label id
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      7. context exact
        1 INDICATIONS AND USAGE ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced
        kind
        regimen
        polarity
        not_inferred
        span
        end
        212
        end exclusive
        true
        exact text
        in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epiderma
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      regulatory links
        schema version
        0.1.0
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        source defined aliases
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          exact text
          1 INDICATIONS AND USAGE ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] .
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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
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA219249
          brand names
          1. Itovebi
          classification reasons
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          exact text
          2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 )
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          qualifier mentions
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            span
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          2. context exact
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          3. context exact
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          4. context exact
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          5. context exact
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            kind
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            span
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            exact text
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          6. context exact
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          7. context exact
            ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic
            kind
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            end exclusive
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            exact text
            in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth facto
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              ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
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              al growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ( 1 , 14.1 )
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                    Preserved source evidence · Not medical advice