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LABELS · ef421dc8-11db-4e6c-9154-dc04782cb52c

JAYPIRCA

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
2026-03-06
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE JAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. ( 1.2 ). 1.1 Mantle Cell Lymphoma JAYPIRCA ® is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma JAYPIRCA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
Full extracted label fields
application numbers
  1. NDA216059
boxed warning exact
    brand names
    1. JAYPIRCA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bd551845-0878-49a4-860f-839b83f6b801
    generic names
    1. PIRTOBRUTINIB
    id
    ef421dc8-11db-4e6c-9154-dc04782cb52c
    indications and usage exact
    1. 1 INDICATIONS AND USAGE JAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. ( 1.2 ). 1.1 Mantle Cell Lymphoma JAYPIRCA ® is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma JAYPIRCA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Eli Lilly and Company
      matched search terms
      1. lymphoma
      2. leukemia
      package ndcs
      1. 0002-6902-30
      2. 0002-7026-60
      3. 0002-7026-99
      product ndcs
      1. 0002-7026
      2. 0002-6902
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma ( 1.2 ) 12/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2629343
      2. 2629349
      3. 2629351
      4. 2629353
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.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
      700
      total
      830
      sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      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=700&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22ef421dc8-11db-4e6c-9154-dc04782cb52c%22
      spl effective date
      2026-03-06
      spl effective time
      20260306
      spl set id
      bd551845-0878-49a4-860f-839b83f6b801
      spl version
      14
      substance names
      1. PIRTOBRUTINIB
      uniis
      1. JNA39I7ZVB
      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
        NDA216059
        payload
        all indexed label documents
        1. Appl No
          216059
          Application Docs Date
          2023-01-31 00:00:00
          Application Docs ID
          73350
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          216059
          Application Docs Date
          2023-12-01 00:00:00
          Application Docs ID
          76716
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          216059
          Application Docs Date
          2024-06-05 00:00:00
          Application Docs ID
          78652
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          216059
          Application Docs Date
          2025-12-08 00:00:00
          Application Docs ID
          84352
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          216059
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2025-12-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          216059
          Review Priority
          901 REQUIRED
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2024-06-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          216059
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-12-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          216059
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-01-27 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA216059
        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
        2025-12-02
        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
          216059
          Application Docs Date
          2025-12-08 00:00:00
          Application Docs ID
          84352
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        official application record
        Appl No
        216059
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        LOXO ONCOL
        openfda application present
        true
        products
        1. Active Ingredient
          PIRTOBRUTINIB
          Appl No
          216059
          Drug Name
          JAYPIRCA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Prescription
        2. Active Ingredient
          PIRTOBRUTINIB
          Appl No
          216059
          Drug Name
          JAYPIRCA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          100MG
          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. NDA216059
      brand names
      1. JAYPIRCA
      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
      431
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE JAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit
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      current approval status
      not_reconciled
      duplicate text group
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      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. PIRTOBRUTINIB
      id
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      label id
      ef421dc8-11db-4e6c-9154-dc04782cb52c
      positive predicate support span
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      66
      end exclusive
      true
      exact text
      is a kinase inhibitor indicated
      label id
      ef421dc8-11db-4e6c-9154-dc04782cb52c
      offset unit
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      qualifier mentions
      1. context exact
        RCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) afte
        kind
        age
        polarity
        not_inferred
        span
        end
        103
        end exclusive
        true
        exact text
        Adult patients
        label id
        ef421dc8-11db-4e6c-9154-dc04782cb52c
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      2. context exact
        hibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, includi
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        152
        end exclusive
        true
        exact text
        relapsed or refractory mantle cell lymphoma
        label id
        ef421dc8-11db-4e6c-9154-dc04782cb52c
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        unicode_code_points
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      3. context exact
        ents with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        230
        end exclusive
        true
        exact text
        after at least two lines of systemic therapy, including a BTK inhibitor
        label id
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        offset unit
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        source text sha256
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      regulatory links
        schema version
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        source defined aliases
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          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE JAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
          label id
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          source text sha256
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          source url
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          spl effective date
          2026-03-06
          spl set id
          bd551845-0878-49a4-860f-839b83f6b801
          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 · unclassified context
          application numbers
          1. NDA216059
          brand names
          1. JAYPIRCA
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          440
          end exclusive
          true
          exact text
          ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a conf
          label id
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          offset unit
          unicode_code_points
          source array index
          0
          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. PIRTOBRUTINIB
          id
          ind-span-d230d4c6a2e1feb1e0cc
          label id
          ef421dc8-11db-4e6c-9154-dc04782cb52c
          positive predicate support span
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          qualifier mentions
            regulatory links
              schema version
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                end exclusive
                true
                exact text
                ( 1.1 ).
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                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22ef421dc8-11db-4e6c-9154-dc04782cb52c%22
                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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                Source null
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                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
                Passage 3 · approval contingency
                application numbers
                1. NDA216059
                brand names
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                classification reasons
                1. approval_contingency_words
                clinical review status
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                content role
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                519
                end exclusive
                true
                exact text
                inase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic
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                current approval status
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                duplicate text group
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                extraction review status
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                generic names
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                id
                ind-span-5b14f5283de3166350b2
                label id
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                positive predicate support span
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                      end exclusive
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                      This indication is approved under accelerated approval based on response rate.
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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
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                      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
                      not_applicable
                      Passage 4 · approval contingency
                      application numbers
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                      brand names
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                      classification reasons
                      1. approval_contingency_words
                      clinical review status
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                      end exclusive
                      true
                      exact text
                      refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. ( 1.2 ). 1.1 Mantle Cel
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                      current approval status
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                      duplicate text group
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                      extraction review status
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                      generic names
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                      id
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                      label id
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                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
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                          source batch sha256
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                            455
                            end exclusive
                            true
                            exact text
                            Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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                            320
                            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
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                                                        PIRCA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have pr
                                                        kind
                                                        stage_or_setting
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        1267
                                                        end exclusive
                                                        true
                                                        exact text
                                                        relapsed or refractory chronic lymphocytic
                                                        label id
                                                        ef421dc8-11db-4e6c-9154-dc04782cb52c
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                                                        unicode_code_points
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                                                        source text sha256
                                                        cc685e878e890323e95d97e47c4c70e71d314e2a06adb1245d27a4afc08b4520
                                                        start
                                                        1224
                                                      regulatory links
                                                        schema version
                                                        0.1.0
                                                        source batch sha256
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                                                          1379
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                                                          exact text
                                                          1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma JAYPIRCA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
                                                          label id
                                                          ef421dc8-11db-4e6c-9154-dc04782cb52c
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                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
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                                                          source text sha256
                                                          cc685e878e890323e95d97e47c4c70e71d314e2a06adb1245d27a4afc08b4520
                                                          start
                                                          1101
                                                          source url
                                                          https://api.fda.gov/drug/label.json?search=id%3A%22ef421dc8-11db-4e6c-9154-dc04782cb52c%22
                                                          spl effective date
                                                          2026-03-06
                                                          spl set id
                                                          bd551845-0878-49a4-860f-839b83f6b801
                                                          spl version
                                                          14
                                                          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

                                                          Preserved source evidence · Not medical advice