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LABELS · ce1c79cc-4b9f-404c-995b-9cce0418ecc4

DARZALEX

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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
2026-06-05
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 DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. ( 1 )
Full extracted label fields
application numbers
  1. BLA761036
boxed warning exact
    brand names
    1. DARZALEX
    2. Darzalex IV
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4d0efe9-5e54-467e-9eb4-56fa7d53b60b
    generic names
    1. DARATUMUMAB
    id
    ce1c79cc-4b9f-404c-995b-9cce0418ecc4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Biotech, Inc.
      matched search terms
      1. myeloma
      package ndcs
      1. 57894-502-05
      2. 57894-502-20
      3. 57894-505-05
      4. 57894-505-20
      product ndcs
      1. 57894-502
      2. 57894-505
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.3 ) 06/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1721951
      2. 1721956
      3. 1726439
      4. 1726440
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
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      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22ce1c79cc-4b9f-404c-995b-9cce0418ecc4%22
      spl effective date
      2026-06-05
      spl effective time
      20260605
      spl set id
      a4d0efe9-5e54-467e-9eb4-56fa7d53b60b
      spl version
      44
      substance names
      1. DARATUMUMAB
      uniis
      1. 4Z63YK6E0E
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        BLA761036
        payload
        all indexed label documents
        1. Appl No
          761036
          Application Docs Date
          2015-11-19 00:00:00
          Application Docs ID
          20002
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761036
          Application Docs Date
          2016-11-18 00:00:00
          Application Docs ID
          45910
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          761036
          Application Docs Date
          2016-11-21 00:00:00
          Application Docs ID
          45931
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          761036
          Application Docs Date
          2017-06-19 00:00:00
          Application Docs ID
          48761
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        5. Appl No
          761036
          Application Docs Date
          2018-05-08 00:00:00
          Application Docs ID
          54056
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        6. Appl No
          761036
          Application Docs Date
          2018-06-21 00:00:00
          Application Docs ID
          54674
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        7. Appl No
          761036
          Application Docs Date
          2019-02-11 00:00:00
          Application Docs ID
          57499
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        8. Appl No
          761036
          Application Docs Date
          2019-06-27 00:00:00
          Application Docs ID
          59184
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          20
          Submission Type
          SUPPL
        9. Appl No
          761036
          Application Docs Date
          2019-07-31 00:00:00
          Application Docs ID
          59361
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        10. Appl No
          761036
          Application Docs Date
          2019-09-26 00:00:00
          Application Docs ID
          60121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        11. Appl No
          761036
          Application Docs Date
          2020-04-27 00:00:00
          Application Docs ID
          62682
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          27
          Submission Type
          SUPPL
        12. Appl No
          761036
          Application Docs Date
          2020-06-30 00:00:00
          Application Docs ID
          63755
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          26
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          61
          Submission Status
          AP
          Submission Status Date
          2026-05-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          54
          Submission Status
          AP
          Submission Status Date
          2025-04-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          51
          Submission Status
          AP
          Submission Status Date
          2025-01-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          50
          Submission Status
          AP
          Submission Status Date
          2024-07-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          45
          Submission Status
          AP
          Submission Status Date
          2022-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          44
          Submission Status
          AP
          Submission Status Date
          2023-01-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          41
          Submission Status
          AP
          Submission Status Date
          2022-03-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          40
          Submission Status
          AP
          Submission Status Date
          2022-01-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          35
          Submission Status
          AP
          Submission Status Date
          2021-07-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          33
          Submission Status
          AP
          Submission Status Date
          2021-03-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2020-08-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          761036
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2020-04-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761036
        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
        2026-05-28
        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
          761036
          Application Docs Date
          2026-06-01 00:00:00
          Application Docs ID
          86092
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          61
          Submission Type
          SUPPL
        official application record
        Appl No
        761036
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        JANSSEN BIOTECH
        openfda application present
        true
        products
        1. Active Ingredient
          DARATUMUMAB
          Appl No
          761036
          Drug Name
          DARZALEX
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          2
          Reference Standard
          Strength
          100MG/5ML
          marketing status
          1. Prescription
        2. Active Ingredient
          DARATUMUMAB
          Appl No
          761036
          Drug Name
          DARZALEX
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          2
          Reference Standard
          Strength
          400MG/20ML
          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. BLA761036
      brand names
      1. DARZALEX
      2. Darzalex IV
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      1481
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who
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      qualifier mentions
      1. context exact
        ATIONS AND USAGE DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and
        kind
        age
        polarity
        not_inferred
        span
        end
        81
        end exclusive
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        span
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        exact text
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      3. context exact
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        polarity
        not_inferred
        span
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        exact text
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      4. context exact
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      5. context exact
        nd in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone i
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        end exclusive
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      6. context exact
        n combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patie
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      7. context exact
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      8. context exact
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                    Preserved source evidence · Not medical advice