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LABELS · 7bfd2975-f348-4a3b-890e-63006967b82a

Sarclisa

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
2026-07-07
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). SARCLISA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). ( 1 )
Full extracted label fields
application numbers
  1. BLA761113
boxed warning exact
    brand names
    1. Sarclisa
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0473462-6f9d-4eca-a5bf-8620aea68e8a
    generic names
    1. ISATUXIMAB
    id
    7bfd2975-f348-4a3b-890e-63006967b82a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). SARCLISA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sanofi-Aventis U.S. LLC
      matched search terms
      1. myeloma
      package ndcs
      1. 0024-0654-01
      2. 0024-0656-01
      product ndcs
      1. 0024-0654
      2. 0024-0656
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.1 ) 6/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2282023
      2. 2282028
      3. 2282031
      4. 2282032
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%227bfd2975-f348-4a3b-890e-63006967b82a%22
      spl effective date
      2026-07-07
      spl effective time
      20260707
      spl set id
      a0473462-6f9d-4eca-a5bf-8620aea68e8a
      spl version
      20
      substance names
      1. ISATUXIMAB
      uniis
      1. R30772KCU0
      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
        BLA761113
        payload
        all indexed label documents
        1. Appl No
          761113
          Application Docs Date
          2020-03-02 00:00:00
          Application Docs ID
          62005
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761113
          Application Docs Date
          2021-03-19 00:00:00
          Application Docs ID
          66813
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          761113
          Application Docs Date
          2021-03-31 00:00:00
          Application Docs ID
          66935
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          761113
          Application Docs Date
          2022-07-19 00:00:00
          Application Docs ID
          71596
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        5. Appl No
          761113
          Application Docs Date
          2023-11-02 00:00:00
          Application Docs ID
          76033
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        6. Appl No
          761113
          Application Docs Date
          2024-09-20 00:00:00
          Application Docs ID
          79674
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        7. Appl No
          761113
          Application Docs Date
          2024-10-28 00:00:00
          Application Docs ID
          80028
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        8. Appl No
          761113
          Application Docs Date
          2024-10-28 00:00:00
          Application Docs ID
          80029
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        9. Appl No
          761113
          Application Docs Date
          2026-07-06 00:00:00
          Application Docs ID
          86468
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-03-02 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2021-03-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2021-03-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2022-07-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2023-11-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2024-10-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2024-10-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          761113
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2024-09-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          761113
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2026-06-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761113
        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
        2026-06-26
        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
          761113
          Application Docs Date
          2026-07-06 00:00:00
          Application Docs ID
          86468
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        official application record
        Appl No
        761113
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        SANOFI AVENTIS US
        openfda application present
        true
        products
        1. Active Ingredient
          ISATUXIMAB-IRFC
          Appl No
          761113
          Drug Name
          SARCLISA
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          100MG/5ML (20MG/ML)
          marketing status
          1. Prescription
        2. Active Ingredient
          ISATUXIMAB-IRFC
          Appl No
          761113
          Drug Name
          SARCLISA
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          0
          Reference Standard
          0
          Strength
          500MG/25ML (20MG/ML)
          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. BLA761113
      brand names
      1. Sarclisa
      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
      837
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). SARCLISA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 pr
      label id
      7bfd2975-f348-4a3b-890e-63006967b82a
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      4461a1a19dc9c31e97e063941fcb68bba433d8e61ce8340920c59c0d8e2d389d
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-2ec69ae52083ae78b0c0
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ISATUXIMAB
      id
      ind-span-fcdcf6d10bdef2dbbe1a
      label id
      7bfd2975-f348-4a3b-890e-63006967b82a
      positive predicate support span
      end
      45
      end exclusive
      true
      exact text
      is indicated
      label id
      7bfd2975-f348-4a3b-890e-63006967b82a
      offset unit
      unicode_code_points
      source array index
      0
      source field
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      source text sha256
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      start
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      qualifier mentions
      1. context exact
        n with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior th
        kind
        age
        polarity
        not_inferred
        span
        end
        134
        end exclusive
        true
        exact text
        adult patients
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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      2. context exact
        on with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have recei
        kind
        age
        polarity
        not_inferred
        span
        end
        339
        end exclusive
        true
        exact text
        adult patients
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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      3. context exact
        omib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible
        kind
        age
        polarity
        not_inferred
        span
        end
        534
        end exclusive
        true
        exact text
        adult patients
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4461a1a19dc9c31e97e063941fcb68bba433d8e61ce8340920c59c0d8e2d389d
        start
        520
      4. context exact
        and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        388
        end exclusive
        true
        exact text
        relapsed or refractory multiple myeloma who
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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      5. context exact
        , for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        251
        end exclusive
        true
        exact text
        who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4461a1a19dc9c31e97e063941fcb68bba433d8e61ce8340920c59c0d8e2d389d
        start
        157
      6. context exact
        adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexameth
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        432
        end exclusive
        true
        exact text
        who have received 1 to 3 prior lines of therapy
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        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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        start
        385
      7. context exact
        1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib a
        kind
        regimen
        polarity
        not_inferred
        span
        end
        226
        end exclusive
        true
        exact text
        in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide a
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
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        source field
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        source text sha256
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        start
        47
      8. context exact
        herapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexameth
        kind
        regimen
        polarity
        not_inferred
        span
        end
        432
        end exclusive
        true
        exact text
        in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        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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        start
        253
      9. context exact
        le myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
        kind
        regimen
        polarity
        not_inferred
        span
        end
        613
        end exclusive
        true
        exact text
        in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem
        label id
        7bfd2975-f348-4a3b-890e-63006967b82a
        offset unit
        unicode_code_points
        source array index
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        source field
        indications_and_usage_exact
        source text sha256
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        start
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      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
          source span
          end
          637
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
          label id
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          offset unit
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          source field
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%227bfd2975-f348-4a3b-890e-63006967b82a%22
          spl effective date
          2026-07-07
          spl set id
          a0473462-6f9d-4eca-a5bf-8620aea68e8a
          spl version
          20
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          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
          Passage 2 · positive indication candidate
          application numbers
          1. BLA761113
          brand names
          1. Sarclisa
          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
          1291
          end exclusive
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          exact text
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              Passage 3 · unclassified context
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                    use intent
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                    Preserved source evidence · Not medical advice