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LABELS · c5c6cd04-1bea-4809-a830-b1fb1ba94e97

DATROWAY

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-05-27
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ] . ( 1.2 ) adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. ( 1.3 ) 1.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. 1.2 Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ]. 1.3 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
Full extracted label fields
application numbers
  1. BLA761394
boxed warning exact
    brand names
    1. DATROWAY
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0
    generic names
    1. DATOPOTAMAB DERUXTECAN
    id
    c5c6cd04-1bea-4809-a830-b1fb1ba94e97
    indications and usage exact
    1. 1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ] . ( 1.2 ) adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. ( 1.3 ) 1.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. 1.2 Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ]. 1.3 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Daiichi Sankyo Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 65597-801-01
      product ndcs
      1. 65597-801
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1.2 ) 05/2026 Dosage and Administration ( 2.3 ) 05/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 05/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2703040
      2. 2703046
      source batch
      file
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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
      limit
      100
      skip
      600
      total
      830
      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=600&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22c5c6cd04-1bea-4809-a830-b1fb1ba94e97%22
      spl effective date
      2026-05-27
      spl effective time
      20260527
      spl set id
      2950227c-6230-4ca4-a135-46e44d9424a0
      spl version
      18
      substance names
      1. DATOPOTAMAB DERUXTECAN
      uniis
      1. GD2OWY1DTK
      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
        BLA761394
        payload
        all indexed label documents
        1. Appl No
          761394
          Application Docs Date
          2025-01-17 00:00:00
          Application Docs ID
          80876
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761394
          Application Docs Date
          2026-06-02 00:00:00
          Application Docs ID
          86132
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761394
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-01-17 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761394
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2026-05-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761394
        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
        2026-05-22
        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
          761394
          Application Docs Date
          2026-06-02 00:00:00
          Application Docs ID
          86132
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        official application record
        Appl No
        761394
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        DAIICHI SANKYO INC
        openfda application present
        true
        products
        1. Active Ingredient
          DATOPOTAMAB DERUXTECAN-DLNK
          Appl No
          761394
          Drug Name
          DATROWAY
          Form
          INJECTABLE; IV (INFUSION)
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          100MG
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. BLA761394
      brand names
      1. DATROWAY
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
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      545
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      true
      exact text
      1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be
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      generic names
      1. DATOPOTAMAB DERUXTECAN
      id
      ind-span-677e0238d1c42a8d8357
      label id
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      true
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      is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated
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      qualifier mentions
      1. context exact
        omerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor
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        age
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        147
        end exclusive
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        adult patients
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      2. context exact
        r the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        216
        end exclusive
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      3. context exact
        ly advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and plati
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        biomarker
        polarity
        not_inferred
        span
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        end exclusive
        true
        exact text
        EGFR)-mutated non-small cell lung cancer (NS
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      4. context exact
        non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        335
        end exclusive
        true
        exact text
        EGFR-directed therapy and platinum-based che
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      5. context exact
        njugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCL
        kind
        stage_or_setting
        polarity
        not_inferred
        span
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        204
        end exclusive
        true
        exact text
        locally advanced or metastatic epidermal growth fac
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        source text sha256
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      6. context exact
        receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        344
        end exclusive
        true
        exact text
        who have received prior EGFR-directed therapy and platinum-based chemotherapy
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      regulatory links
      1. candidate source span
        end
        345
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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        fda indication exact
        Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
        fda source row index
        12
        fda source sha256
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        fda status record id
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        interpretation
        Source wording correspondence to a dated FDA status row; current approval not certified
        match method
        whole_indication_literal_normalized_substring
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        whole_fda_indication_text_present
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          definition exact
          non-small cell lung cancer
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          end exclusive
          true
          exact text
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        exact text
        1 INDICATIONS AND USAGE DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
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        source url
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        spl effective date
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        spl set id
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        structured fields status
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        Source null
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        Source null
        biomarker and test
        Source null
        disease stage
        Source null
        limitations
        Source null
        line
        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate

        Read indication-specific status → · whole_fda_indication_text_present

        Passage 2 · approval contingency
        application numbers
        1. BLA761394
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        s with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negativ
        label id
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        generic names
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        id
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        positive predicate support span
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            source batch sha256
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            source defined aliases
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              definition exact
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              exact text
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            ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] .
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            source url
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            spl effective date
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            spl set id
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            spl version
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            structured fields status
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            limitations
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            use intent
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            Passage 3 · approval contingency
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            1. BLA761394
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            1. DATROWAY
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                          Read indication-specific status → · whole_fda_indication_text_present

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                                    definition exact
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                                  application numbers
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                                  true
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                                      Preserved source evidence · Not medical advice