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LABELS · 32956dbc-6fe7-4e40-8496-cead92e453b7

UNLOXCYT

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
2025-12-08
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 UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
Full extracted label fields
application numbers
  1. BLA761297
boxed warning exact
    brand names
    1. UNLOXCYT
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06bdadd5-d2db-406f-a3f8-de47f48a52e3
    generic names
    1. COSIBELIMAB
    id
    32956dbc-6fe7-4e40-8496-cead92e453b7
    indications and usage exact
    1. 1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Sun Pharmaceutical Industries, Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 70095-130-01
      product ndcs
      1. 70095-130
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 2717518
        2. 2717525
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
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        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2232956dbc-6fe7-4e40-8496-cead92e453b7%22
        spl effective date
        2025-12-08
        spl effective time
        20251208
        spl set id
        06bdadd5-d2db-406f-a3f8-de47f48a52e3
        spl version
        3
        substance names
        1. COSIBELIMAB
        uniis
        1. PNW7GBB44P
        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
          BLA761297
          payload
          all indexed label documents
          1. Appl No
            761297
            Application Docs Date
            2024-12-16 00:00:00
            Application Docs ID
            80576
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761297
            Application Docs Date
            2025-11-25 00:00:00
            Application Docs ID
            84294
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            761297
            Application Docs Date
            2026-09-01 00:00:00
            Application Docs ID
            87112
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761297
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-12-13 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761297
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-11-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761297
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2026-08-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761297
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
          2026-08-31
          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
            761297
            Application Docs Date
            2026-09-01 00:00:00
            Application Docs ID
            87112
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          official application record
          Appl No
          761297
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          CHECKPOINT THERAPEUTICS INC
          openfda application present
          true
          products
          1. Active Ingredient
            COSIBELIMAB-IPDL
            Appl No
            761297
            Drug Name
            UNLOXCYT
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            300MG/5ML(60MG/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 · unclassified context
        application numbers
        1. BLA761297
        brand names
        1. UNLOXCYT
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
        pending
        content role
        unclassified_context
        context span
        end
        202
        end exclusive
        true
        exact text
        1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative
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        id
        ind-span-65fc8852de41aa9cbe52
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        positive predicate support span
        Source null
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              Source null
              disease stage
              Source null
              limitations
              Source null
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              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              unclear
              Passage 2 · positive indication candidate
              application numbers
              1. BLA761297
              brand names
              1. UNLOXCYT
              classification reasons
              1. explicit_positive_indication_predicate
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              clinical review status
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              exact text
              1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who
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              generic names
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              exact text
              is indicated
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              qualifier mentions
              1. context exact
                ATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) o
                kind
                age
                polarity
                not_inferred
                span
                end
                74
                end exclusive
                true
                exact text
                adults
                label id
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              2. context exact
                SAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not cand
                kind
                biomarker
                polarity
                not_inferred
                span
                end
                123
                end exclusive
                true
                exact text
                metastatic cutaneous squamous cell carcinom
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              3. context exact
                SAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candid
                kind
                stage_or_setting
                polarity
                not_inferred
                span
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                end exclusive
                true
                exact text
                metastatic cutaneous squamous cell carcinoma
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              4. context exact
                ith metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
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                end exclusive
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                exact text
                locally advanced CSCC (laCSCC) who are not candidat
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              regulatory links
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                  end exclusive
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                  exact text
                  INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
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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
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                  disease stage
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                  limitations
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                  prior therapy
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                  regimen
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                  tumor histology
                  Source null
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                  Passage 3 · positive indication candidate
                  application numbers
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                  brand names
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                  exact text
                  is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
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                  is a programmed death ligand-1 (PD-L1) blocking antibody indicated
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                    UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell ca
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                    PD-L1) blocking antibody indicated for the tr
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                      exact text
                      UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
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                      source url
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                      spl effective date
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                      structured fields status
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                      structured indication
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                      approval pathway
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                      biomarker and test
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                      limitations
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                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
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                      Preserved source evidence · Not medical advice