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LABELS · 8441efc2-338a-4d1d-8fa1-9b9863a49ffd

EMPLICITI

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
2022-03-22
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 • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1)
Full extracted label fields
application numbers
  1. BLA761035
boxed warning exact
    brand names
    1. EMPLICITI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80686b7e-f6f4-4154-b5c0-c846425e2d91
    generic names
    1. ELOTUZUMAB
    id
    8441efc2-338a-4d1d-8fa1-9b9863a49ffd
    indications and usage exact
    1. 1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. E.R. Squibb & Sons, L.L.C.
      matched search terms
      1. myeloma
      package ndcs
      1. 0003-2291-11
      2. 0003-4522-11
      product ndcs
      1. 0003-2291
      2. 0003-4522
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1726110
        2. 1726115
        3. 1726117
        4. 1726119
        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%228441efc2-338a-4d1d-8fa1-9b9863a49ffd%22
        spl effective date
        2022-03-22
        spl effective time
        20220322
        spl set id
        80686b7e-f6f4-4154-b5c0-c846425e2d91
        spl version
        13
        substance names
        1. ELOTUZUMAB
        uniis
        1. 1351PE5UGS
        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
          BLA761035
          payload
          all indexed label documents
          1. Appl No
            761035
            Application Docs Date
            2015-11-30 00:00:00
            Application Docs ID
            40640
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761035
            Application Docs Date
            2017-05-15 00:00:00
            Application Docs ID
            48380
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          3. Appl No
            761035
            Application Docs Date
            2018-11-08 00:00:00
            Application Docs ID
            56365
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          4. Appl No
            761035
            Application Docs Date
            2019-10-29 00:00:00
            Application Docs ID
            60700
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          5. Appl No
            761035
            Application Docs Date
            2022-03-28 00:00:00
            Application Docs ID
            70616
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761035
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2015-11-30 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761035
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2017-05-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761035
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2018-11-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            761035
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2019-10-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            761035
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2022-03-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761035
          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
          2022-03-22
          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
            761035
            Application Docs Date
            2022-03-28 00:00:00
            Application Docs ID
            70616
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          official application record
          Appl No
          761035
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          BRISTOL MYERS SQUIBB
          openfda application present
          true
          products
          1. Active Ingredient
            ELOTUZUMAB
            Appl No
            761035
            Drug Name
            EMPLICITI
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            Strength
            300MG
            marketing status
            1. Prescription
          2. Active Ingredient
            ELOTUZUMAB
            Appl No
            761035
            Drug Name
            EMPLICITI
            Form
            INJECTABLE;INJECTION
            Product No
            002
            Reference Drug
            0
            Reference Standard
            Strength
            400MG
            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 · unclassified context
        application numbers
        1. BLA761035
        brand names
        1. EMPLICITI
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
        pending
        content role
        unclassified_context
        context span
        end
        223
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is in
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        current approval status
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        duplicate text group
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        extraction review status
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        generic names
        1. ELOTUZUMAB
        id
        ind-span-1358fb72962c01ab9b06
        label id
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        positive predicate support span
        Source null
        qualifier mentions
          regulatory links
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              1 INDICATIONS AND USAGE
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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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              structured indication
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              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
              Passage 2 · positive indication candidate
              application numbers
              1. BLA761035
              brand names
              1. EMPLICITI
              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
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              405
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              true
              exact text
              1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalido
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              duplicate text group
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              extraction review status
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              generic names
              1. ELOTUZUMAB
              id
              ind-span-92708e6a068f1efc1a4a
              label id
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              positive predicate support span
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              true
              exact text
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              qualifier mentions
              1. context exact
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                kind
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                end exclusive
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              2. context exact
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                span
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                end exclusive
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                exact text
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              3. context exact
                • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
                kind
                regimen
                polarity
                not_inferred
                span
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                204
                end exclusive
                true
                exact text
                in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies
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                  • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
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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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                  structured indication
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                  Source null
                  approval pathway
                  Source null
                  biomarker and test
                  Source null
                  disease stage
                  Source null
                  limitations
                  Source null
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                  prior therapy
                  Source null
                  regimen
                  Source null
                  tumor histology
                  Source null
                  use intent
                  tumor_directed_candidate
                  Passage 3 · positive indication candidate
                  application numbers
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                  brand names
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                  classification reasons
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                  clinical review status
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                  637
                  end exclusive
                  true
                  exact text
                  CATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received on
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                  2. context exact
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                  3. context exact
                    • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
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                      • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
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                      source url
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                      spl effective date
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                      regimen
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                      tumor histology
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                      use intent
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                      Passage 4 · positive indication candidate
                      application numbers
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                      ination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dex
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                            EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in
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                            source url
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                            spl set id
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                            approval pathway
                            Source null
                            biomarker and test
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                            disease stage
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                            limitations
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                            Source null
                            prior therapy
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                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            non_oncology_or_unclear_candidate
                            Passage 5 · unclassified context
                            application numbers
                            1. BLA761035
                            brand names
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                            classification reasons
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                            true
                            exact text
                            patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome
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                            current approval status
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                            id
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                            label id
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                            2. context exact
                              e for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
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                              663
                              end exclusive
                              true
                              exact text
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                            regulatory links
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                              source batch sha256
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                                end exclusive
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                                exact text
                                • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.
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                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%228441efc2-338a-4d1d-8fa1-9b9863a49ffd%22
                                spl effective date
                                2022-03-22
                                spl set id
                                80686b7e-f6f4-4154-b5c0-c846425e2d91
                                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
                                Passage 6 · unclassified context
                                application numbers
                                1. BLA761035
                                brand names
                                1. EMPLICITI
                                classification reasons
                                1. no_unambiguous_positive_indication_predicate
                                clinical review status
                                pending
                                content role
                                unclassified_context
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                                868
                                end exclusive
                                true
                                exact text
                                ted immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhi
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                                current approval status
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                                duplicate text group
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                                      end exclusive
                                      true
                                      exact text
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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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                                      structured indication
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                                      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
                                      Passage 7 · unclassified context
                                      application numbers
                                      1. BLA761035
                                      brand names
                                      1. EMPLICITI
                                      classification reasons
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                                      clinical review status
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                                      content role
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                                      878
                                      end exclusive
                                      true
                                      exact text
                                      immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1)
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                                      current approval status
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                                      duplicate text group
                                      dup-ee6648f0b183b52b4dcf
                                      extraction review status
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                                      1. ELOTUZUMAB
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                                      label id
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                                        873
                                        end exclusive
                                        true
                                        exact text
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                                      regulatory links
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                                          874
                                          end exclusive
                                          true
                                          exact text
                                          • combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
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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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                                          structured indication
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                                          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
                                          Passage 8 · unclassified context
                                          application numbers
                                          1. BLA761035
                                          brand names
                                          1. EMPLICITI
                                          classification reasons
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                                          clinical review status
                                          pending
                                          content role
                                          unclassified_context
                                          context span
                                          end
                                          878
                                          end exclusive
                                          true
                                          exact text
                                          ination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1)
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                                          current approval status
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                                          duplicate text group
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                                                878
                                                end exclusive
                                                true
                                                exact text
                                                (1)
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                                                source url
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                                                structured fields status
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                                                approval pathway
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                                                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