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LABELS · 7ab778c9-5f92-4e53-bfe8-8db8d3bd3ef3

PEMAZYRE

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
2026-06-09
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1 , 2.1 ) 1.1 Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
Full extracted label fields
application numbers
  1. NDA213736
boxed warning exact
    brand names
    1. PEMAZYRE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e1f2222-1d89-4e63-989c-ccebe2ab1eb4
    generic names
    1. PEMIGATINIB
    id
    7ab778c9-5f92-4e53-bfe8-8db8d3bd3ef3
    indications and usage exact
    1. 1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1 , 2.1 ) 1.1 Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Incyte Corporation
      matched search terms
      1. neoplasms
      package ndcs
      1. 50881-026-01
      2. 50881-027-01
      3. 50881-028-01
      product ndcs
      1. 50881-026
      2. 50881-027
      3. 50881-028
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage, Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement ( 1.2 ) 8/2022 Dosage and Administration, Recommended Dosage ( 2.2 ) 8/2022 Warnings and Precautions, Ocular Toxicity ( 5.1 ) 8/2022 Warnings and Precautions, Hyperphosphatemia and Soft Tissue Mineralization ( 5.2 ) 8/2022
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2359334
      2. 2359340
      3. 2359342
      4. 2359344
      5. 2359346
      6. 2359348
      source batch
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      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      400
      total
      830
      sha256
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      url
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      source url
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      spl effective date
      2026-06-09
      spl effective time
      20260609
      spl set id
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      spl version
      17
      substance names
      1. PEMIGATINIB
      uniis
      1. Y6BX7BL23K
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA213736
        payload
        all indexed label documents
        1. Appl No
          213736
          Application Docs Date
          2020-04-20 00:00:00
          Application Docs ID
          62593
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
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        2. Appl No
          213736
          Application Docs Date
          2021-02-24 00:00:00
          Application Docs ID
          66341
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          213736
          Application Docs Date
          2022-08-26 00:00:00
          Application Docs ID
          71937
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          213736
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-04-17 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          213736
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-02-23 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          213736
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2022-08-26 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
        NDA213736
        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2022-08-26
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        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
          213736
          Application Docs Date
          2022-08-26 00:00:00
          Application Docs ID
          71937
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          2
          Submission Type
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        official application record
        Appl No
        213736
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        INCYTE CORP
        openfda application present
        true
        products
        1. Active Ingredient
          PEMIGATINIB
          Appl No
          213736
          Drug Name
          PEMAZYRE
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          4.5MG
          marketing status
          1. Prescription
        2. Active Ingredient
          PEMIGATINIB
          Appl No
          213736
          Drug Name
          PEMAZYRE
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          9MG
          marketing status
          1. Prescription
        3. Active Ingredient
          PEMIGATINIB
          Appl No
          213736
          Drug Name
          PEMAZYRE
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          13.5MG
          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. NDA213736
      brand names
      1. PEMAZYRE
      classification reasons
      1. explicit_positive_indication_predicate
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
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      499
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification
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      generic names
      1. PEMIGATINIB
      id
      ind-span-85e046263e71d5fc849c
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      exact text
      is a kinase inhibitor indicated
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      qualifier mentions
      1. context exact
        AZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or m
        kind
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        polarity
        not_inferred
        span
        end
        93
        end exclusive
        true
        exact text
        adults
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      2. context exact
        s with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearra
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        biomarker
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        not_inferred
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        end exclusive
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        exact text
        metastatic cholangiocarcinoma with a fibrob
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      3. context exact
        langiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
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        exact text
        FGFR2) fusion or other rearrangement as detec
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      4. context exact
        cated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (
        kind
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        not_inferred
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        true
        exact text
        unresectable locally advanced or metastatic cho
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      5. context exact
        inase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
        kind
        prior_therapy_or_line
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        end exclusive
        true
        exact text
        previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by
        label id
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      regulatory links
      1. candidate source span
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        299
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
        label id
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        fda indication exact
        Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
        fda source row index
        55
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          exact text
          1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
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          non_oncology_or_unclear_candidate

          Read indication-specific status → · whole_fda_indication_text_present

          Passage 2 · approval contingency
          application numbers
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          reviously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or ref
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                ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response.
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                Passage 3 · approval contingency
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                exact text
                (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. ( 1 , 2.1 ) 1.1 Cholangiocarcinoma PEMAZYRE is indicated for the treatm
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                                    Read indication-specific status → · whole_fda_indication_text_present

                                    Passage 7 · approval contingency
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                                                Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                                                te and duration of response [see Clinical Studies ( 14.1 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
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                                                is indicated
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                                                  R1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLN
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                                                  relapsed or refractory myeloid/lymphoid neo
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                                                    1.2 Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
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                                                    Preserved source evidence · Not medical advice