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LABELS · 9209fc63-aee3-43dc-9bc6-16c5ed73d858

Rolvedon

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
2026-02-18
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
Full extracted label fields
application numbers
  1. BLA761148
boxed warning exact
    brand names
    1. Rolvedon
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e436115-62e7-4729-aeb0-ff78ea685206
    generic names
    1. EFLAPEGRASTIM-XNST
    id
    9209fc63-aee3-43dc-9bc6-16c5ed73d858
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Spectrum Pharmaceuticals, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 76961-101-01
      product ndcs
      1. 76961-101
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration, Administration ( 2.2 ) 07/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 2612541
      2. 2612547
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00500.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
      500
      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%229209fc63-aee3-43dc-9bc6-16c5ed73d858%22
      spl effective date
      2026-02-18
      spl effective time
      20260218
      spl set id
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      spl version
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      substance names
      1. EFLAPEGRASTIM
      uniis
      1. UT99UG9QJX
      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
        BLA761148
        payload
        all indexed label documents
        1. Appl No
          761148
          Application Docs Date
          2022-09-16 00:00:00
          Application Docs ID
          72089
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761148
          Application Docs Date
          2023-06-20 00:00:00
          Application Docs ID
          74546
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          761148
          Application Docs Date
          2025-12-18 00:00:00
          Application Docs ID
          84437
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761148
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-09-09 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761148
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2023-06-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761148
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2025-12-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761148
        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
        2025-12-12
        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
          761148
          Application Docs Date
          2025-12-18 00:00:00
          Application Docs ID
          84437
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        official application record
        Appl No
        761148
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        SPECTRUM PHARMS
        openfda application present
        true
        products
        1. Active Ingredient
          EFLAPEGRASTIM-XNST
          Appl No
          761148
          Drug Name
          ROLVEDON
          Form
          INJECTABLE;SUBCUTANEOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          13.2MG/0.6ML
          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. BLA761148
      brand names
      1. Rolvedon
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      489
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to
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      id
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      qualifier mentions
      1. context exact
        ence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive an
        kind
        age
        polarity
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      regulatory links
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        source defined aliases
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          exact text
          1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
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          source text sha256
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          source url
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          spl effective date
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          spl set id
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          approval pathway
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          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
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          prior therapy
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          tumor histology
          Source null
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          Passage 2 · limitation of use
          application numbers
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          1. negative_or_not_established_clause
          clinical review status
          pending
          content role
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          637
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          true
          exact text
          anifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressiv
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          offset unit
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          source text sha256
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          duplicate text group
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          generic names
          1. EFLAPEGRASTIM-XNST
          id
          ind-span-9b5146973eb207e184f1
          label id
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          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
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                end exclusive
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                exact text
                Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                source url
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                spl effective date
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                spl set id
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                structured fields status
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                biomarker and test
                Source null
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                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
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                regimen
                Source null
                tumor histology
                Source null
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                application numbers
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                clinical review status
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                889
                end exclusive
                true
                exact text
                cally significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
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                    Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
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                    source url
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                    anifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
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                          Source null
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                          significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
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                          Source null
                          qualifier mentions
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                              source defined aliases
                                source span
                                end
                                889
                                end exclusive
                                true
                                exact text
                                ( 1 )
                                label id
                                9209fc63-aee3-43dc-9bc6-16c5ed73d858
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                14dca34bd599b0b23fca21f30eb653eac50be523bd689a17f5fc535239d72e69
                                start
                                884
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%229209fc63-aee3-43dc-9bc6-16c5ed73d858%22
                                spl effective date
                                2026-02-18
                                spl set id
                                6e436115-62e7-4729-aeb0-ff78ea685206
                                spl version
                                6
                                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