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LABELS · 600cd22c-3a74-442e-a65d-c06d47bb892a

KYPROLIS

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
2025-06-18
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 Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1 , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1 , 14 ) 1.1 Relapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. Kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Full extracted label fields
application numbers
  1. NDA202714
boxed warning exact
    brand names
    1. KYPROLIS
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
    generic names
    1. CARFILZOMIB
    id
    600cd22c-3a74-442e-a65d-c06d47bb892a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1 , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1 , 14 ) 1.1 Relapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. Kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Onyx Pharmaceuticals, Inc.
      matched search terms
      1. myeloma
      package ndcs
      1. 76075-101-01
      2. 76075-101-21
      3. 76075-102-01
      4. 76075-102-21
      5. 76075-103-01
      6. 76075-103-21
      product ndcs
      1. 76075-101
      2. 76075-102
      3. 76075-103
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1806934
        2. 1806937
        3. 1806940
        4. 1806942
        5. 2046642
        6. 2046644
        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%22600cd22c-3a74-442e-a65d-c06d47bb892a%22
        spl effective date
        2025-06-18
        spl effective time
        20250618
        spl set id
        ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
        spl version
        59
        substance names
        1. CARFILZOMIB
        uniis
        1. 72X6E3J5AR
        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
          NDA202714
          payload
          all indexed label documents
          1. Appl No
            202714
            Application Docs Date
            2012-07-20 00:00:00
            Application Docs ID
            19368
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            202714
            Application Docs Date
            2015-04-07 00:00:00
            Application Docs ID
            19369
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          3. Appl No
            202714
            Application Docs Date
            2016-07-06 00:00:00
            Application Docs ID
            19370
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          4. Appl No
            202714
            Application Docs Date
            2015-07-24 00:00:00
            Application Docs ID
            40207
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          5. Appl No
            202714
            Application Docs Date
            2016-01-26 00:00:00
            Application Docs ID
            40208
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          6. Appl No
            202714
            Application Docs Date
            2016-05-25 00:00:00
            Application Docs ID
            40209
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          7. Appl No
            202714
            Application Docs Date
            2016-08-04 00:00:00
            Application Docs ID
            44998
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          8. Appl No
            202714
            Application Docs Date
            2016-12-01 00:00:00
            Application Docs ID
            45986
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          9. Appl No
            202714
            Application Docs Date
            2017-05-30 00:00:00
            Application Docs ID
            48559
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          10. Appl No
            202714
            Application Docs Date
            2018-01-18 00:00:00
            Application Docs ID
            51091
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            17
            Submission Type
            SUPPL
          11. Appl No
            202714
            Application Docs Date
            2018-06-11 00:00:00
            Application Docs ID
            54493
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          12. Appl No
            202714
            Application Docs Date
            2018-10-03 00:00:00
            Application Docs ID
            55793
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            202714
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            2025-05-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            34
            Submission Status
            AP
            Submission Status Date
            2022-06-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            33
            Submission Status
            AP
            Submission Status Date
            2021-11-30 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            32
            Submission Status
            AP
            Submission Status Date
            2021-03-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            30
            Submission Status
            AP
            Submission Status Date
            2020-08-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            29
            Submission Status
            AP
            Submission Status Date
            2020-05-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2019-10-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2019-02-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            202714
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2018-09-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2018-06-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2018-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            202714
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2017-05-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA202714
          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
          2025-05-22
          latest label selection rule
          max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
          latest posted label documents
          1. Appl No
            202714
            Application Docs Date
            2025-06-02 00:00:00
            Application Docs ID
            82410
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          official application record
          Appl No
          202714
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          ONYX PHARMS AMGEN
          openfda application present
          true
          products
          1. Active Ingredient
            CARFILZOMIB
            Appl No
            202714
            Drug Name
            KYPROLIS
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            60MG/VIAL
            marketing status
            1. Prescription
          2. Active Ingredient
            CARFILZOMIB
            Appl No
            202714
            Drug Name
            KYPROLIS
            Form
            POWDER;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            30MG/VIAL
            marketing status
            1. Prescription
          3. Active Ingredient
            CARFILZOMIB
            Appl No
            202714
            Drug Name
            KYPROLIS
            Form
            POWDER;INTRAVENOUS
            Product No
            003
            Reference Drug
            1
            Reference Standard
            1
            Strength
            10MG/VIAL
            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. NDA202714
        brand names
        1. KYPROLIS
        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
        600
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1 , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1 , 14 ) 1.1 Relapsed or Refractory Multiple
        label id
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        source array index
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        source text sha256
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        current approval status
        not_reconciled
        duplicate text group
        dup-45bf7ab75334c2a30c83
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. CARFILZOMIB
        id
        ind-span-c5f52e41c4741dccc233
        label id
        600cd22c-3a74-442e-a65d-c06d47bb892a
        positive predicate support span
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        end exclusive
        true
        exact text
        is a proteasome inhibitor that is indicated
        label id
        600cd22c-3a74-442e-a65d-c06d47bb892a
        offset unit
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        source array index
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        source field
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        source text sha256
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        start
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        qualifier mentions
        1. context exact
          roteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have recei
          kind
          age
          polarity
          not_inferred
          span
          end
          113
          end exclusive
          true
          exact text
          adult patients
          label id
          600cd22c-3a74-442e-a65d-c06d47bb892a
          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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        2. context exact
          that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
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          end exclusive
          true
          exact text
          relapsed or refractory multiple myeloma who
          label id
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          source field
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          source text sha256
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        3. context exact
          adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Dar
          kind
          prior_therapy_or_line
          polarity
          not_inferred
          span
          end
          257
          end exclusive
          true
          exact text
          who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone
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          source text sha256
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        4. context exact
          ple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Dar
          kind
          regimen
          polarity
          not_inferred
          span
          end
          257
          end exclusive
          true
          exact text
          in combination with Lenalidomide and dexamethasone
          label id
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          source text sha256
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        regulatory links
          schema version
          0.1.0
          source batch sha256
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          source defined aliases
            source span
            end
            400
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone.
            label id
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            source array index
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            source field
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            source text sha256
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            source url
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            spl effective date
            2025-06-18
            spl set id
            ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
            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. NDA202714
            brand names
            1. KYPROLIS
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
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            content role
            positive_indication_candidate
            context span
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            752
            end exclusive
            true
            exact text
            erapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1 , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1 , 14 ) 1.1 Relapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of t
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            current approval status
            not_reconciled
            duplicate text group
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            extraction review status
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            generic names
            1. CARFILZOMIB
            id
            ind-span-714a61845e4f01ebe5b2
            label id
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            positive predicate support span
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            end exclusive
            true
            exact text
            is a proteasome inhibitor that is indicated
            label id
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            offset unit
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            qualifier mentions
            1. context exact
              , 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              508
              end exclusive
              true
              exact text
              relapsed or refractory multiple myeloma who
              label id
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              source field
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              source text sha256
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              start
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            2. context exact
              nt of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
              kind
              prior_therapy_or_line
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