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LABELS · ade5aa80-b303-470f-8e79-7edea0c4a1bc

PLUVICTO

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
2026-08-12
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. ( 1.2 ) 1.1 Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PLUVICTO is indicated in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. 1.2 Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer PLUVICTO is indicated for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.
Full extracted label fields
application numbers
  1. NDA215833
boxed warning exact
    brand names
    1. PLUVICTO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14908037-2892-4d98-a053-253ce35afb1a
    generic names
    1. LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN
    id
    ade5aa80-b303-470f-8e79-7edea0c4a1bc
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. ( 1.2 ) 1.1 Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PLUVICTO is indicated in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. 1.2 Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer PLUVICTO is indicated for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Novartis Pharmaceuticals Corporation
      matched search terms
      1. cancer
      package ndcs
      1. 0078-1217-61
      product ndcs
      1. 0078-1217
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1.1 ) 7/2026 Dosage and Administration, Patient Selection ( 2.2 ) 7/2026 Dosage and Administration, Recommended Dosage ( 2.3 ) 7/2026 Dosage and Administration, Radiation Dosimetry ( 2.6 ) 4/2026 Warnings and Precautions, Myelosuppression ( 5.2 ) 7/2026 Warnings and Precautions, Renal Toxicity ( 5.3 ) 7/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2597057
      2. 2597060
      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
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      total
      830
      sha256
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      url
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      source url
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      spl effective date
      2026-08-12
      spl effective time
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      spl set id
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      spl version
      5
      substance names
      1. LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
      uniis
      1. G6UF363ECX
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
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      Drugs@FDA application source records
      1. application number
        NDA215833
        payload
        all indexed label documents
        1. Appl No
          215833
          Application Docs Date
          2022-03-23 00:00:00
          Application Docs ID
          70591
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          215833
          Application Docs Date
          2026-03-02 00:00:00
          Application Docs ID
          81781
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        3. Appl No
          215833
          Application Docs Date
          2026-03-02 00:00:00
          Application Docs ID
          81782
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        4. Appl No
          215833
          Application Docs Date
          2026-04-10 00:00:00
          Application Docs ID
          85667
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          35
          Submission Type
          SUPPL
        5. Appl No
          215833
          Application Docs Date
          2026-08-04 00:00:00
          Application Docs ID
          86801
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          37
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          215833
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-03-23 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          215833
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2025-03-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          215833
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2025-03-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          215833
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          35
          Submission Status
          AP
          Submission Status Date
          2026-04-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          215833
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          37
          Submission Status
          AP
          Submission Status Date
          2026-07-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA215833
        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
        2026-07-31
        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
          215833
          Application Docs Date
          2026-08-04 00:00:00
          Application Docs ID
          86801
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          37
          Submission Type
          SUPPL
        official application record
        Appl No
        215833
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
          Appl No
          215833
          Drug Name
          PLUVICTO
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          27mCi/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. NDA215833
      brand names
      1. PLUVICTO
      classification reasons
      1. explicit_positive_indication_predicate
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      clinical review status
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      content role
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      true
      exact text
      1 INDICATIONS AND USAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prosta
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      1. LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN
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      is a radioligand therapeutic agent indicated
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      qualifier mentions
      1. context exact
        eptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive met
        kind
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        polarity
        not_inferred
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      2. context exact
        SAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination wit
        kind
        biomarker
        polarity
        not_inferred
        span
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        end exclusive
        true
        exact text
        Metastatic Androgen Pathway Modulation-Naïv
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      3. context exact
        of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.
        kind
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        polarity
        not_inferred
        span
        end
        356
        end exclusive
        true
        exact text
        PSMA)-positive metastatic androgen pathway m
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      4. context exact
        SAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with
        kind
        stage_or_setting
        polarity
        not_inferred
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        end exclusive
        true
        exact text
        Metastatic Androgen Pathway Modulation-Naïve
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      5. context exact
        nts with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.
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      6. context exact
        ay Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostat
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        exact text
        in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic andro
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      regulatory links
        schema version
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          1 INDICATIONS AND USAGE PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.
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          spl effective date
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          Source null
          disease stage
          Source null
          limitations
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          line
          Source null
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          Source null
          regimen
          Source null
          tumor histology
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          Passage 2 · positive indication candidate
          application numbers
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          ibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. ( 1.2 ) 1.1 Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PLUVICTO is indicated in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment o
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          qualifier mentions
          1. context exact
            tion-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-r
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          2. context exact
            ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult pat
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            Metastatic Androgen Pathway Modulation-Resi
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          3. context exact
            R) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been tre
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            not_inferred
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            PSMA-positive metastatic androgen pathway mo
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          4. context exact
            ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patie
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            Metastatic Androgen Pathway Modulation-Resist
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                            Preserved source evidence · Not medical advice