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LABELS · 0142c57f-6211-4638-8c48-c215686871b8

Lynparza

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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
2025-07-10
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.1 , 2.1 ) • in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.2 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.3 , 2.1 ) Breast cancer • for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.4 , 2.1 ) • for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.5 , 2.1 ) Pancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.6 , 2.1 ) Prostate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.7 , 2.1 ) • in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.8 , 2.1 ) 1.1 First-Line Maintenance Treatment of BRCA -mutated Advanced Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . 1.2 First-line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ]. 1.3 Maintenance Treatment of BRCA-mutated Recurrent Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ]. 1.4 Adjuvant Treatment of Germline BRCA -mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [ see Dosage and Administration (2.1) ]. 1.5 Germline BRCA -mutated HER2-negative Metastatic Breast Cancer Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . 1.6 First-Line Maintenance Treatment of Germline BRCA -mutated Metastatic Pancreatic Adenocarcinoma Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . 1.7 HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ]. 1.8 Treatment of BRCA -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] .
Full extracted label fields
application numbers
  1. NDA208558
boxed warning exact
    brand names
    1. Lynparza
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=741ff3e3-dc1a-45a6-84e5-2481b27131aa
    generic names
    1. OLAPARIB
    id
    0142c57f-6211-4638-8c48-c215686871b8
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.1 , 2.1 ) • in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.2 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.3 , 2.1 ) Breast cancer • for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.4 , 2.1 ) • for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.5 , 2.1 ) Pancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.6 , 2.1 ) Prostate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.7 , 2.1 ) • in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.8 , 2.1 ) 1.1 First-Line Maintenance Treatment of BRCA -mutated Advanced Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . 1.2 First-line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ]. 1.3 Maintenance Treatment of BRCA-mutated Recurrent Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ]. 1.4 Adjuvant Treatment of Germline BRCA -mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [ see Dosage and Administration (2.1) ]. 1.5 Germline BRCA -mutated HER2-negative Metastatic Breast Cancer Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . 1.6 First-Line Maintenance Treatment of Germline BRCA -mutated Metastatic Pancreatic Adenocarcinoma Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . 1.7 HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ]. 1.8 Treatment of BRCA -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] .
    indications and usage tables exact
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      manufacturer names
      1. AstraZeneca Pharmaceuticals LP
      matched search terms
      1. cancer
      package ndcs
      1. 0310-0668-60
      2. 0310-0668-12
      3. 0310-0668-95
      4. 0310-0679-60
      5. 0310-0679-12
      6. 0310-0679-95
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      9. 0310-0578-60
      10. 0310-0578-12
      product ndcs
      1. 0310-0569
      2. 0310-0668
      3. 0310-0679
      4. 0310-0578
      product types
      1. HUMAN PRESCRIPTION DRUG
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      1. Warnings and Precautions ( 5.2 , 5.4 ) 7/2025
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      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.
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      source url
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      spl effective date
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      spl effective time
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      substance names
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      Drugs@FDA application source records
      1. application number
        NDA208558
        payload
        all indexed label documents
        1. Appl No
          208558
          Application Docs Date
          2017-08-17 00:00:00
          Application Docs ID
          49443
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          208558
          Application Docs Date
          2018-01-12 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
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        3. Appl No
          208558
          Application Docs Date
          2018-02-07 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          208558
          Application Docs Date
          2018-09-27 00:00:00
          Application Docs ID
          55632
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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        5. Appl No
          208558
          Application Docs Date
          2018-12-19 00:00:00
          Application Docs ID
          56808
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        6. Appl No
          208558
          Application Docs Date
          2019-07-09 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        7. Appl No
          208558
          Application Docs Date
          2020-01-10 00:00:00
          Application Docs ID
          61467
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        8. Appl No
          208558
          Application Docs Date
          2020-05-08 00:00:00
          Application Docs ID
          62859
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        9. Appl No
          208558
          Application Docs Date
          2020-05-19 00:00:00
          Application Docs ID
          63150
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        10. Appl No
          208558
          Application Docs Date
          2020-11-03 00:00:00
          Application Docs ID
          65135
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        11. Appl No
          208558
          Application Docs Date
          2020-12-10 00:00:00
          Application Docs ID
          65563
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        12. Appl No
          208558
          Application Docs Date
          2021-03-12 00:00:00
          Application Docs ID
          66770
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        all submission records
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          208558
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2025-07-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          208558
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2023-09-12 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          208558
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2023-11-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          208558
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2022-08-26 00:00:00
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          Submissions Public Notes
        5. Appl No
          208558
          Review Priority
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          2
          Submission No
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          AP
          Submission Status Date
          2023-05-31 00:00:00
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          Submissions Public Notes
        6. Appl No
          208558
          Review Priority
          STANDARD
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          Submissions Public Notes
        7. Appl No
          208558
          Review Priority
          PRIORITY
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          Submission No
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          Submission Status Date
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          Submissions Public Notes
        8. Appl No
          208558
          Review Priority
          STANDARD
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          Submission No
          21
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        9. Appl No
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        10. Appl No
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          2021-03-11 00:00:00
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        11. Appl No
          208558
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2020-11-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          208558
          Review Priority
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          Submission No
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          Submission Status
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          Submission Status Date
          2020-12-07 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
        NDA208558
        approval interpretation
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        current indication status
        not_reconciled
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        latest approved submission date
        2025-07-10
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        latest posted label documents
        1. Appl No
          208558
          Application Docs Date
          2025-07-11 00:00:00
          Application Docs ID
          82819
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          31
          Submission Type
          SUPPL
        official application record
        Appl No
        208558
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ASTRAZENECA
        openfda application present
        true
        products
        1. Active Ingredient
          OLAPARIB
          Appl No
          208558
          Drug Name
          LYNPARZA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          100MG
          marketing status
          1. Prescription
        2. Active Ingredient
          OLAPARIB
          Appl No
          208558
          Drug Name
          LYNPARZA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          150MG
          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 · indication intro context
      application numbers
      1. NDA208558
      brand names
      1. Lynparza
      classification reasons
      1. explicit_positive_indication_predicate
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      end
      309
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      exact text
      1 INDICATIONS AND USAGE Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
      label id
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                                                                                        1880
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                                                                                          Passage 17 · unclassified context
                                                                                          application numbers
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                                                                                                                                                            application numbers
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                                                                                                                                                            brand names
                                                                                                                                                            1. Lynparza
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                                                                                                                                                              1.1 First-Line Maintenance Treatment of BRCA -mutated Advanced Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patie
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                                                                                                                                                            4. context exact
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                                                                                                                                                            6. context exact
                                                                                                                                                              1.1 First-Line Maintenance Treatment of BRCA -mutated Advanced Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced e
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                                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                                  1. NDA208558
                                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                                  1. Lynparza
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                                                                                                                                                                                                                                                    h deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
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                                                                                                                                                                                                                                                    CA -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated
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                                                                                                                                                                                                                                                      1.8 Treatment of BRCA -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
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                                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                                      1. NDA208558
                                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                                      1. Lynparza
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                                                                                                                                                                                                                                                            use intent
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                                                                                                                                                                                                                                                            Preserved source evidence · Not medical advice