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LABELS · 3851a6cd-d487-2012-e063-6394a90aa33e

ANKTIVA

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
2025-06-24
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
Full extracted label fields
application numbers
  1. BLA761336
boxed warning exact
    brand names
    1. ANKTIVA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eae31db8-3e7a-d9e0-708d-74419d1b50ff
    generic names
    1. NOGAPENDEKIN ALFA INBAKICEPT-PMLN
    id
    3851a6cd-d487-2012-e063-6394a90aa33e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
      matched search terms
      1. cancer
      2. carcinoma
      3. tumors
      package ndcs
      1. 81481-803-01
      product ndcs
      1. 81481-803
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVESICAL
        rxcuis
        1. 2682684
        2. 2682691
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.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
        200
        total
        830
        sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        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=200&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%223851a6cd-d487-2012-e063-6394a90aa33e%22
        spl effective date
        2025-06-24
        spl effective time
        20250624
        spl set id
        eae31db8-3e7a-d9e0-708d-74419d1b50ff
        spl version
        9
        substance names
        1. NOGAPENDEKIN ALFA INBAKICEPT-PMLN
        uniis
        1. 7TK323DLA0
        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
          BLA761336
          payload
          all indexed label documents
          1. Appl No
            761336
            Application Docs Date
            2024-04-22 00:00:00
            Application Docs ID
            78202
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761336
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-04-22 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          BLA761336
          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
          2024-04-22
          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
            761336
            Application Docs Date
            2024-04-22 00:00:00
            Application Docs ID
            78202
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          761336
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
          openfda application present
          true
          products
          1. Active Ingredient
            nogapendekin alfa inbakicept-pmln
            Appl No
            761336
            Drug Name
            ANKTIVA
            Form
            SOLUTION;INTRAVESICAL
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            400mcg/0.4 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. BLA761336
        brand names
        1. ANKTIVA
        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
        458
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC)
        label id
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        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        e03c62db4ffa55e961a97caceddd9319329419c04c006ececb0d35871ac2bd6b
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-a3d1c392bee95c273177
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. NOGAPENDEKIN ALFA INBAKICEPT-PMLN
        id
        ind-span-3884a615cc39672b85f8
        label id
        3851a6cd-d487-2012-e063-6394a90aa33e
        positive predicate support span
        end
        95
        end exclusive
        true
        exact text
        is indicated
        label id
        3851a6cd-d487-2012-e063-6394a90aa33e
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        83
        qualifier mentions
        1. context exact
          lus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NM
          kind
          age
          polarity
          not_inferred
          span
          end
          131
          end exclusive
          true
          exact text
          adult patients
          label id
          3851a6cd-d487-2012-e063-6394a90aa33e
          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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          start
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        2. context exact
          1 INDICATIONS AND USAGE ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          211
          end exclusive
          true
          exact text
          in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma
          label id
          3851a6cd-d487-2012-e063-6394a90aa33e
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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          start
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        3. context exact
          nvasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          257
          end exclusive
          true
          exact text
          with or without papillary tumors
          label id
          3851a6cd-d487-2012-e063-6394a90aa33e
          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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          start
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
            source span
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            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
            label id
            3851a6cd-d487-2012-e063-6394a90aa33e
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e03c62db4ffa55e961a97caceddd9319329419c04c006ececb0d35871ac2bd6b
            start
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%223851a6cd-d487-2012-e063-6394a90aa33e%22
            spl effective date
            2025-06-24
            spl set id
            eae31db8-3e7a-d9e0-708d-74419d1b50ff
            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. BLA761336
            brand names
            1. ANKTIVA
            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
            527
            end exclusive
            true
            exact text
            s Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
            label id
            3851a6cd-d487-2012-e063-6394a90aa33e
            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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            current approval status
            not_reconciled
            duplicate text group
            dup-1fe50b09950eddfdd282
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. NOGAPENDEKIN ALFA INBAKICEPT-PMLN
            id
            ind-span-23faa68282f06d627d48
            label id
            3851a6cd-d487-2012-e063-6394a90aa33e
            positive predicate support span
            end
            322
            end exclusive
            true
            exact text
            is an interleukin-15 (IL-15) receptor agonist indicated
            label id
            3851a6cd-d487-2012-e063-6394a90aa33e
            offset unit
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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
              ed with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NM
              kind
              age
              polarity
              not_inferred
              span
              end
              394
              end exclusive
              true
              exact text
              adult patients
              label id
              3851a6cd-d487-2012-e063-6394a90aa33e
              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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              start
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            2. context exact
              nvasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
              kind
              regimen
              polarity
              not_inferred
              span
              end
              520
              end exclusive
              true
              exact text
              with or without papillary tumors
              label id
              3851a6cd-d487-2012-e063-6394a90aa33e
              offset unit
              unicode_code_points
              source array index
              0
              source field
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              source text sha256
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              start
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            regulatory links
              schema version
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              source batch sha256
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              source defined aliases
                source span
                end
                521
                end exclusive
                true
                exact text
                ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
                label id
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                offset unit
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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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                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 3 · unclassified context
                application numbers
                1. BLA761336
                brand names
                1. ANKTIVA
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
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                content role
                unclassified_context
                context span
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                527
                end exclusive
                true
                exact text
                with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
                label id
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                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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                current approval status
                not_reconciled
                duplicate text group
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                extraction review status
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                generic names
                1. NOGAPENDEKIN ALFA INBAKICEPT-PMLN
                id
                ind-span-5350bd82a50d7224a751
                label id
                3851a6cd-d487-2012-e063-6394a90aa33e
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
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                    source batch sha256
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                      exact text
                      ( 1 )
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                      offset unit
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                      source array index
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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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                      spl version
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                      structured fields status
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                      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