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LABELS · a4106ba4-f398-4663-980c-2b7195283edd

Enhertu

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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
2026-05-15
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ] . WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Interstitial lung disease (ILD) and pneumonitis, including severe, life threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. ( 2.3 , 5.1 ) Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception. ( 5.4 , 8.1 , 8.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. ( 1.1 ) HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test. ( 1.2 ) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. ( 1.2 ) HER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting. ( 1.3 ) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. ( 1.3 ) HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy* ( 1.4 ) HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. ( 1.5 ) HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options* ( 1.6 ) * These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 14.3 , 14.5 ) 1.1 HER2-Positive Early Breast Cancer ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. ENHERTU is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. 1.2 HER2-Positive Metastatic Breast Cancer ENHERTU, in combination with pertuzumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. 1.3 HER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting [see Dosage and Administration (2.1) ] . HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] . 1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.4) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.5 HER2-Positive Locally Advanced or Metastatic Gastric Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. 1.6 HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.6) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Full extracted label fields
application numbers
  1. BLA761139
boxed warning exact
  1. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial Lung Disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and the need to immediately report symptoms [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . Embryo-Fetal Toxicity: Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ] . WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Interstitial lung disease (ILD) and pneumonitis, including severe, life threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. ( 2.3 , 5.1 ) Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception. ( 5.4 , 8.1 , 8.3 )
brand names
  1. Enhertu
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7e67e73e-ddf4-4e4d-8b50-09d7514910b6
generic names
  1. FAM-TRASTUZUMAB DERUXTECAN-NXKI
id
a4106ba4-f398-4663-980c-2b7195283edd
indications and usage exact
  1. 1 INDICATIONS AND USAGE ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP). ( 1.1 ) as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. ( 1.1 ) HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test. ( 1.2 ) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. ( 1.2 ) HER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting. ( 1.3 ) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. ( 1.3 ) HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy* ( 1.4 ) HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. ( 1.5 ) HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options* ( 1.6 ) * These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 14.3 , 14.5 ) 1.1 HER2-Positive Early Breast Cancer ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. ENHERTU is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment. 1.2 HER2-Positive Metastatic Breast Cancer ENHERTU, in combination with pertuzumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. 1.3 HER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting [see Dosage and Administration (2.1) ] . HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] . 1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.4) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.5 HER2-Positive Locally Advanced or Metastatic Gastric Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. 1.6 HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.6) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Daiichi Sankyo Inc.
    matched search terms
    1. cancer
    2. tumors
    package ndcs
    1. 65597-406-01
    product ndcs
    1. 65597-406
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage ( 1.1 ) 05/2026 Indications and Usage ( 1.2 ) 12/2025 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 05/2026 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 05/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 12/2025
    record type
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    routes
    1. INTRAVENOUS
    rxcuis
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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
    results
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    sha256
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    url
    https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=500&sort=id%3Aasc
    source url
    https://api.fda.gov/drug/label.json?search=id%3A%22a4106ba4-f398-4663-980c-2b7195283edd%22
    spl effective date
    2026-05-15
    spl effective time
    20260515
    spl set id
    7e67e73e-ddf4-4e4d-8b50-09d7514910b6
    spl version
    28
    substance names
    1. TRASTUZUMAB DERUXTECAN
    uniis
    1. 5384HK7574
    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
    4. fda_label_posted_after_spl_effective_date_requires_version_review
    Drugs@FDA application source records
    1. application number
      BLA761139
      payload
      all indexed label documents
      1. Appl No
        761139
        Application Docs Date
        2019-12-20 00:00:00
        Application Docs ID
        61369
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761139
        Application Docs Date
        2021-01-15 00:00:00
        Application Docs ID
        65916
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      3. Appl No
        761139
        Application Docs Date
        2022-05-04 00:00:00
        Application Docs ID
        70995
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      4. Appl No
        761139
        Application Docs Date
        2022-05-04 00:00:00
        Application Docs ID
        70996
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        20
        Submission Type
        SUPPL
      5. Appl No
        761139
        Application Docs Date
        2022-08-11 00:00:00
        Application Docs ID
        71776
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        22
        Submission Type
        SUPPL
      6. Appl No
        761139
        Application Docs Date
        2022-08-11 00:00:00
        Application Docs ID
        71778
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      7. Appl No
        761139
        Application Docs Date
        2022-11-07 00:00:00
        Application Docs ID
        72568
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        24
        Submission Type
        SUPPL
      8. Appl No
        761139
        Application Docs Date
        2024-02-16 00:00:00
        Application Docs ID
        77510
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        26
        Submission Type
        SUPPL
      9. Appl No
        761139
        Application Docs Date
        2024-04-05 00:00:00
        Application Docs ID
        78077
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        28
        Submission Type
        SUPPL
      10. Appl No
        761139
        Application Docs Date
        2025-02-05 00:00:00
        Application Docs ID
        80922
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        32
        Submission Type
        SUPPL
      11. Appl No
        761139
        Application Docs Date
        2025-02-05 00:00:00
        Application Docs ID
        80923
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        35
        Submission Type
        SUPPL
      12. Appl No
        761139
        Application Docs Date
        2025-12-18 00:00:00
        Application Docs ID
        84459
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        38
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761139
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        41
        Submission Status
        AP
        Submission Status Date
        2026-05-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        761139
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        42
        Submission Status
        AP
        Submission Status Date
        2025-12-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        43
        Submission Status
        AP
        Submission Status Date
        2026-05-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        761139
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        39
        Submission Status
        AP
        Submission Status Date
        2026-04-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        38
        Submission Status
        AP
        Submission Status Date
        2025-12-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761139
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        35
        Submission Status
        AP
        Submission Status Date
        2025-01-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        32
        Submission Status
        AP
        Submission Status Date
        2025-01-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        28
        Submission Status
        AP
        Submission Status Date
        2024-04-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        761139
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        26
        Submission Status
        AP
        Submission Status Date
        2024-02-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        24
        Submission Status
        AP
        Submission Status Date
        2022-11-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        22
        Submission Status
        AP
        Submission Status Date
        2022-08-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        761139
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2022-08-11 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761139
      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
      2026-05-15
      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
        761139
        Application Docs Date
        2026-05-19 00:00:00
        Application Docs ID
        85977
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        41
        Submission Type
        SUPPL
      2. Appl No
        761139
        Application Docs Date
        2026-05-19 00:00:00
        Application Docs ID
        85978
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        43
        Submission Type
        SUPPL
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      Appl No
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      Appl Public Notes
      Appl Type
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      Sponsor Name
      DAIICHI SANKYO
      openfda application present
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      products
      1. Active Ingredient
        FAM-TRASTUZUMAB DERUXTECAN-NXKI
        Appl No
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        Drug Name
        ENHERTU
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        2
        Reference Standard
        0
        Strength
        100MG
        marketing status
        1. Prescription

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                                ( 1.5 ) HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options* ( 1.6 ) * These indications are approved under accelerated approval based on objective response rate and duration of response.
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                                Passage 12 · approval contingency
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                                    Passage 13 · unclassified context
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                                              1.2 HER2-Positive Metastatic Breast Cancer ENHERTU, in combination with pertuzumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test [see Dosage and Administratio
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                                              1.2 HER2-Positive Metastatic Breast Cancer ENHERTU, in combination with pertuzumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ].
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                                              he first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. 1.3 HER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-l
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                                                ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or IS
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                                                rapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2
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                                              8. context exact
                                                ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in t
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                                                as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-H
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                                                  ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-posit
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                                                2. context exact
                                                  1.3 HER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatm
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                                                3. context exact
                                                  ed for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with
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                                                  4524
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                                                  metastatic Hormone receptor (HR)-positive H
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                                                  4481
                                                4. context exact
                                                  receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, tha
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                                                  4603
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                                                  HER2-ultralow (IHC 0 with membrane staining)
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                                                5. context exact
                                                  at has progressed on one or more endocrine therapies in the metastatic setting [see Dosage and Administration (2.1) ] .
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                                                  4765
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                                                  metastatic setting [see Dosage and Administ
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                                                6. context exact
                                                  1.3 HER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult pa
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                                                  at has progressed on one or more endocrine therapies in the metastatic setting [see Dosage and Administration (2.1) ] .
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                                                  ER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determi
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                                                  as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultra
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                                                  1.3 HER2-Low and HER2-Ultralow Metastatic Breast Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic Hormone receptor (HR)-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting [see Dosage and Administration (2.1) ] .
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                                                  th membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting [see Dosage and Administration (2.1) ] . HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] . 1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung can
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                                                    horized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemo
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                                                    disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] .
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                                                    H-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] .
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                                                    HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] .
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                                                    Passage 20 · positive indication candidate
                                                    application numbers
                                                    1. BLA761139
                                                    brand names
                                                    1. Enhertu
                                                    classification reasons
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                                                    who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see Dosage and Administration (2.1) ] . 1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.4) ] . Continued approval for this indication may be conting
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                                                    1. context exact
                                                      ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer
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                                                      1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated
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                                                    4. context exact
                                                      small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have receiv
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                                                      HER2 (ERBB2) mutations
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                                                      1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatme
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                                                      Unresectable or Metastatic Non-Small Cell Lung
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                                                      rapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mut
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                                                      unresectable or metastatic non-small cell lung
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                                                    7. context exact
                                                      RBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy.
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                                                      5420
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                                                      who have received a prior systemic therapy
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                                                      5378
                                                    8. context exact
                                                      esectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who ha
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                                                      1.4 HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy.
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                                                                ENHERTU, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ o
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                                                                1.5 HER2-Positive Locally Advanced or Metastatic Gastric Cancer ENHERTU, as monotherapy, is indicated for the treatment of adult
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                                                                tients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. 1.6 HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.6) ] . Continued approval for this indication may be conting
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                                                                6. context exact
                                                                  esectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
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                                                                7. context exact
                                                                  e (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
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                                                                  1.6 HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
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                                                                  fda indication exact
                                                                  Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
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                                                                  24
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                                                                  1.6 HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
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                                                                  Read indication-specific status → · whole_fda_indication_text_present

                                                                  Passage 25 · approval contingency
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                                                                      Passage 26 · approval contingency
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                                                                          Preserved source evidence · Not medical advice