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LABELS · dfebfe9c-a0c5-41d8-bf11-ed643627e264

PERJETA

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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
2026-04-30
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) (8.3) ]. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.3 , 5.1 , 6.1 ) Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. ( 5.2 , 8.1 , 8.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ( 1.1 ) Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ( 1.2 , 2.2 , 14.2 ) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence ( 1.2 , 2.2 , 14.3 ) 1.1 Metastatic Breast Cancer (MBC) PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] . 1.2 Early Breast Cancer (EBC) PERJETA is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] . the adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence [see Dosage and Administration (2.2) and Clinical Studies (14.3) ] .
Full extracted label fields
application numbers
  1. BLA125409
boxed warning exact
  1. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) (8.3) ]. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.3 , 5.1 , 6.1 ) Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. ( 5.2 , 8.1 , 8.3 )
brand names
  1. PERJETA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=17f85d17-ab71-4f5b-9fe3-0b8c822f69ff
generic names
  1. PERTUZUMAB
id
dfebfe9c-a0c5-41d8-bf11-ed643627e264
indications and usage exact
  1. 1 INDICATIONS AND USAGE PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ( 1.1 ) Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ( 1.2 , 2.2 , 14.2 ) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence ( 1.2 , 2.2 , 14.3 ) 1.1 Metastatic Breast Cancer (MBC) PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] . 1.2 Early Breast Cancer (EBC) PERJETA is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] . the adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence [see Dosage and Administration (2.2) and Clinical Studies (14.3) ] .
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genentech, Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 50242-145-01
    product ndcs
    1. 50242-145
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRAVENOUS
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      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
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      url
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      source url
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      spl effective date
      2026-04-30
      spl effective time
      20260430
      spl set id
      17f85d17-ab71-4f5b-9fe3-0b8c822f69ff
      spl version
      27
      substance names
      1. PERTUZUMAB
      uniis
      1. K16AIQ8CTM
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        BLA125409
        payload
        all indexed label documents
        1. Appl No
          125409
          Application Docs Date
          2013-04-16 00:00:00
          Application Docs ID
          18907
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        2. Appl No
          125409
          Application Docs Date
          2013-09-30 00:00:00
          Application Docs ID
          18908
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          51
          Submission Type
          SUPPL
        3. Appl No
          125409
          Application Docs Date
          2015-03-19 00:00:00
          Application Docs ID
          18909
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          104
          Submission Type
          SUPPL
        4. Appl No
          125409
          Application Docs Date
          2015-06-04 00:00:00
          Application Docs ID
          18910
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          105
          Submission Type
          SUPPL
        5. Appl No
          125409
          Application Docs Date
          2012-06-11 00:00:00
          Application Docs ID
          39953
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        6. Appl No
          125409
          Application Docs Date
          2016-03-23 00:00:00
          Application Docs ID
          39954
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          109
          Submission Type
          SUPPL
        7. Appl No
          125409
          Application Docs Date
          2017-12-20 00:00:00
          Application Docs ID
          50794
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          113
          Submission Type
          SUPPL
        8. Appl No
          125409
          Application Docs Date
          2017-12-20 00:00:00
          Application Docs ID
          50795
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          118
          Submission Type
          SUPPL
        9. Appl No
          125409
          Application Docs Date
          2018-10-17 00:00:00
          Application Docs ID
          56003
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          121
          Submission Type
          SUPPL
        10. Appl No
          125409
          Application Docs Date
          2018-12-20 00:00:00
          Application Docs ID
          56904
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          123
          Submission Type
          SUPPL
        11. Appl No
          125409
          Application Docs Date
          2020-01-17 00:00:00
          Application Docs ID
          61587
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          124
          Submission Type
          SUPPL
        12. Appl No
          125409
          Application Docs Date
          2025-05-15 00:00:00
          Application Docs ID
          82193
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          137
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          141
          Submission Status
          AP
          Submission Status Date
          2026-04-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          139
          Submission Status
          AP
          Submission Status Date
          2025-06-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          125409
          Review Priority
          N/A
          Submission Class Code ID
          6
          Submission No
          137
          Submission Status
          AP
          Submission Status Date
          2025-04-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          124
          Submission Status
          AP
          Submission Status Date
          2020-01-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          123
          Submission Status
          AP
          Submission Status Date
          2018-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          121
          Submission Status
          AP
          Submission Status Date
          2018-09-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          125409
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          118
          Submission Status
          AP
          Submission Status Date
          2017-12-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          113
          Submission Status
          AP
          Submission Status Date
          2017-12-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          109
          Submission Status
          AP
          Submission Status Date
          2016-03-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          105
          Submission Status
          AP
          Submission Status Date
          2015-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          125409
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          104
          Submission Status
          AP
          Submission Status Date
          2015-03-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          125409
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2013-09-30 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
        BLA125409
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
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        has approved submission record
        true
        latest approved submission date
        2026-04-23
        latest label selection rule
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        latest posted label documents
        1. Appl No
          125409
          Application Docs Date
          2026-04-24 00:00:00
          Application Docs ID
          85749
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          141
          Submission Type
          SUPPL
        official application record
        Appl No
        125409
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        GENENTECH
        openfda application present
        true
        products
        1. Active Ingredient
          PERTUZUMAB
          Appl No
          125409
          Drug Name
          PERJETA
          Form
          VIAL; SINGLE-USE
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          420MG/14ML
          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
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      brand names
      1. PERJETA
      classification reasons
      1. explicit_positive_indication_predicate
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      exact text
      1 INDICATIONS AND USAGE PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ( 1.1 ) Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2
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      4. context exact
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        ERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
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          1 INDICATIONS AND USAGE PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
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