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LABELS · 3392cd59-0d45-e081-e063-6394a90a0353

Penpulimab kcqx

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
2025-04-24
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). 1.2 Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, as a single agent, is indicated for the treatment of adults with metastatic non-keratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Full extracted label fields
application numbers
  1. BLA761258
boxed warning exact
    brand names
    1. Penpulimab kcqx
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=830004e8-31af-4cc6-ab16-e870cab1c5ca
    generic names
    1. PENPULIMAB
    id
    3392cd59-0d45-e081-e063-6394a90a0353
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). 1.2 Recurrent Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, as a single agent, is indicated for the treatment of adults with metastatic non-keratinizing NPC and disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Akeso Biopharma, Co., Ltd
      matched search terms
      1. carcinoma
      package ndcs
      1. 83654-105-01
      product ndcs
      1. 83654-105
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 2712652
        source batch
        file
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        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
        100
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2025-04-24
        spl effective time
        20250424
        spl set id
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        spl version
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        substance names
        1. PENPULIMAB
        uniis
        1. IBS1BZ4E4I
        verification flags
        1. oncology_keyword_candidate_not_clinically_classified
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        Drugs@FDA application source records
        1. application number
          BLA761258
          payload
          all indexed label documents
          1. Appl No
            761258
            Application Docs Date
            2025-04-24 00:00:00
            Application Docs ID
            81966
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761258
            Application Docs Date
            2026-09-01 00:00:00
            Application Docs ID
            87119
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761258
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-04-23 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761258
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2026-08-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761258
          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
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          latest label selection rule
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          latest posted label documents
          1. Appl No
            761258
            Application Docs Date
            2026-09-01 00:00:00
            Application Docs ID
            87119
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          official application record
          Appl No
          761258
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          AKESO BIOPHARMA
          openfda application present
          true
          products
          1. Active Ingredient
            PENPULIMAB-KCQX
            Appl No
            761258
            Drug Name
            PENPULIMAB-KCQX
            Form
            INJECTABLE;INTRAVENOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            100MG/10ML(10MG/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. BLA761258
        brand names
        1. Penpulimab kcqx
        classification reasons
        1. explicit_positive_indication_predicate
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        clinical review status
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        content role
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        500
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        true
        exact text
        1 INDICATIONS AND USAGE Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2
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        is a programmed death receptor-1 (PD-1)-blocking antibody indicated
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        qualifier mentions
        1. context exact
          carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngea
          kind
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          polarity
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        2. context exact
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        3. context exact
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        4. context exact
          ith either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 )
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          first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1
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        5. context exact
          rammed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 )
          kind
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          exact text
          in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (
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        regulatory links
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          source defined aliases
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            1 INDICATIONS AND USAGE Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 )
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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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            Source null
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            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. BLA761258
            brand names
            1. Penpulimab kcqx
            classification reasons
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            exact text
            icated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicate
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            is a programmed death receptor-1 (PD-1)-blocking antibody indicated
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              metastatic non-keratinizing NPC with diseas
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                as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
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                1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for th
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                              Preserved source evidence · Not medical advice