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LABELS · 564889eb-80a7-336a-e063-6294a90a30c8

Sarclisa Escena

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
2026-07-10
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy 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 ESCENA 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 1 prior line of therapy 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. BLA761445
boxed warning exact
    brand names
    1. Sarclisa Escena
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07730e8c-1340-4d30-8d71-e20f850db8da
    generic names
    1. ISATUXIMAB-IRFC
    id
    564889eb-80a7-336a-e063-6294a90a30c8
    indications and usage exact
    1. 1 INDICATIONS AND USAGE SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy 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 ESCENA 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 1 prior line of therapy 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. 0024-0674-01
      product ndcs
      1. 0024-0674
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2747132
        2. 2747135
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00300.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
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22564889eb-80a7-336a-e063-6294a90a30c8%22
        spl effective date
        2026-07-10
        spl effective time
        20260710
        spl set id
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        spl version
        3
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          BLA761445
          payload
          all indexed label documents
          1. Appl No
            761445
            Application Docs Date
            2026-07-15 00:00:00
            Application Docs ID
            86552
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761445
            Review Priority
            STANDARD
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2026-07-09 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          BLA761445
          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
          2026-07-09
          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
            761445
            Application Docs Date
            2026-07-15 00:00:00
            Application Docs ID
            86552
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          761445
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          SANOFI-AVENTIS U.S. LLC
          openfda application present
          true
          products
          1. Active Ingredient
            ISATUXIMAB-IRFC
            Appl No
            761445
            Drug Name
            SARCLISA ESCENA
            Form
            VIAL;SINGLE-DOSE
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            1400MG/10ML (140MG/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. BLA761445
        brand names
        1. Sarclisa Escena
        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
        850
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy 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 ESCENA 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 lea
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        duplicate text group
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        extraction review status
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        generic names
        1. ISATUXIMAB-IRFC
        id
        ind-span-bc44b9391bef7ff00308
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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 1 prior li
          kind
          age
          polarity
          not_inferred
          span
          end
          141
          end exclusive
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          exact text
          adult patients
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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
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          not_inferred
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          end
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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
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        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
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          end exclusive
          true
          exact text
          relapsed or refractory multiple myeloma who
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        5. context exact
          , for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the
          kind
          prior_therapy_or_line
          polarity
          not_inferred
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          end exclusive
          true
          exact text
          who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor
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        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
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          end exclusive
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          exact text
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        7. context exact
          1 INDICATIONS AND USAGE SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor. in combination with carfilz
          kind
          regimen
          polarity
          not_inferred
          span
          end
          233
          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 1 prior line of therapy including lenalido
          label id
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        8. context exact
          therapy 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
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          445
          end exclusive
          true
          exact text
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        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
          626
          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
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          source defined aliases
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            exact text
            1 INDICATIONS AND USAGE SARCLISA ESCENA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy 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).
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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
            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. BLA761445
            brand names
            1. Sarclisa Escena
            classification reasons
            1. explicit_positive_indication_predicate
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
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            context span
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            1317
            end exclusive
            true
            exact text
            ombination 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 ESCENA 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 1 prior line of therapy 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 )
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              span
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            3. context exact
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              span
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              end exclusive
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              exact text
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            4. context exact
              SARCLISA ESCENA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the
              kind
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              polarity
              not_inferred
              span
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              716
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              exact text
              CD38-directed cytolytic antibody indicated:
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            5. 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
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              1063
              end exclusive
              true
              exact text
              relapsed or refractory multiple myeloma who
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            6. context exact
              , for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the
              kind
              prior_therapy_or_line
              polarity
              not_inferred
              span
              end
              926
              end exclusive
              true
              exact text
              who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor
              label id
              564889eb-80a7-336a-e063-6294a90a30c8
              offset unit
              unicode_code_points
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              source text sha256
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              826
            7. 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 dexametha
              kind
              prior_therapy_or_line
              polarity
              not_inferred
              span
              end
              1107
              end exclusive
              true
              exact text
              who have received 1 to 3 prior lines of therapy
              label id
              564889eb-80a7-336a-e063-6294a90a30c8
              offset unit
              unicode_code_points
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              1060
            8. context exact
              ISA ESCENA 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 1 prior line of therapy including lenalidomide and a proteasome inhibitor. in combination with carfilz
              kind
              regimen
              polarity
              not_inferred
              span
              end
              895
              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 1 prior line of therapy including lenalido
              label id
              564889eb-80a7-336a-e063-6294a90a30c8
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              unicode_code_points
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              source field
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              source text sha256
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              716
            9. context exact
              therapy 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 dexametha
              kind
              regimen
              polarity
              not_inferred
              span
              end
              1107
              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
              564889eb-80a7-336a-e063-6294a90a30c8
              offset unit
              unicode_code_points
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              source field
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              source text sha256
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              928
            10. 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
              1288
              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
              564889eb-80a7-336a-e063-6294a90a30c8
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
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              1109
            regulatory links
              schema version
              0.1.0
              source batch sha256
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              source defined aliases
                source span
                end
                1311
                end exclusive
                true
                exact text
                SARCLISA ESCENA 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 1 prior line of therapy 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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                source field
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                source text sha256
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                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22564889eb-80a7-336a-e063-6294a90a30c8%22
                spl effective date
                2026-07-10
                spl set id
                07730e8c-1340-4d30-8d71-e20f850db8da
                spl version
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                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 3 · unclassified context
                application numbers
                1. BLA761445
                brand names
                1. Sarclisa Escena
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                1317
                end exclusive
                true
                exact text
                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 )
                label id
                564889eb-80a7-336a-e063-6294a90a30c8
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                source array index
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                source field
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                source text sha256
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                current approval status
                not_reconciled
                duplicate text group
                dup-7a8f58254cf70c3e8ee5
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. ISATUXIMAB-IRFC
                id
                ind-span-eeb5d482cd36c2432265
                label id
                564889eb-80a7-336a-e063-6294a90a30c8
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
                    source defined aliases
                      source span
                      end
                      1317
                      end exclusive
                      true
                      exact text
                      ( 1 )
                      label id
                      564889eb-80a7-336a-e063-6294a90a30c8
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      fae3ba1141e426f56c03c69cc123f1f4bb1b6341b336dc26ebcffbcf088cd8de
                      start
                      1312
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22564889eb-80a7-336a-e063-6294a90a30c8%22
                      spl effective date
                      2026-07-10
                      spl set id
                      07730e8c-1340-4d30-8d71-e20f850db8da
                      spl version
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                      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
                      unclear

                      Preserved source evidence · Not medical advice