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LABELS · c4bd8d8a-22c1-4911-a9b4-7368582d8e5d

TAZVERIK

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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
2026-04-29
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 TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. ( 1.2 ) Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. ( 1.2 ) These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.1 Epithelioid Sarcoma TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. 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 Relapsed or Refractory Follicular Lymphoma TAZVERIK is indicated for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )]. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Full extracted label fields
application numbers
  1. NDA211723
boxed warning exact
    brand names
    1. TAZVERIK
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7db07b5f-4e22-467c-9c0a-f830b08dbb1d
    generic names
    1. TAZEMETOSTAT
    id
    c4bd8d8a-22c1-4911-a9b4-7368582d8e5d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. ( 1.2 ) Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. ( 1.2 ) These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.1 Epithelioid Sarcoma TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. 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 Relapsed or Refractory Follicular Lymphoma TAZVERIK is indicated for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )]. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Epizyme, Inc.
      matched search terms
      1. lymphoma
      2. sarcoma
      3. tumors
      package ndcs
      1. 72607-100-00
      product ndcs
      1. 72607-100
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration, Modifications for Drug Interactions ( 2.4 ) 08/2024 Warnings and Precautions, Secondary Malignancies ( 5.1 ) 11/2023
      record type
      complete_spl_indications_section_candidate
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      1. ORAL
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      1. 2274384
      2. 2274390
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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
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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
      2026-04-29
      spl effective time
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      substance names
      1. TAZEMETOSTAT HYDROBROMIDE
      uniis
      1. 6P89T5M073
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA211723
        payload
        all indexed label documents
        1. Appl No
          211723
          Application Docs Date
          2020-01-24 00:00:00
          Application Docs ID
          61636
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          211723
          Application Docs Date
          2023-11-17 00:00:00
          Application Docs ID
          76594
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          211723
          Application Docs Date
          2024-08-14 00:00:00
          Application Docs ID
          79387
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        all submission records
        1. Appl No
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          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
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          Submission Status Date
          2020-01-23 00:00:00
          Submission Type
          ORIG
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        2. Appl No
          211723
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2023-11-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          211723
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2024-08-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA211723
        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2024-08-13
        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
          211723
          Application Docs Date
          2024-08-14 00:00:00
          Application Docs ID
          79387
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
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          Submission Type
          SUPPL
        official application record
        Appl No
        211723
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        EPIZYME INC
        openfda application present
        true
        products
        1. Active Ingredient
          TAZEMETOSTAT HYDROBROMIDE
          Appl No
          211723
          Drug Name
          TAZVERIK
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 200MG BASE
          marketing status
          1. Discontinued

      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. NDA211723
      brand names
      1. TAZVERIK
      classification reasons
      1. explicit_positive_indication_predicate
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      clinical review status
      pending
      content role
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      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior system
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      1. TAZEMETOSTAT
      id
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      true
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      is a methyltransferase inhibitor indicated
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      qualifier mentions
      1. context exact
        methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metasta
        kind
        age
        polarity
        not_inferred
        span
        end
        104
        end exclusive
        true
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        Adults
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      2. context exact
        ferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced
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        127
        end exclusive
        true
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        pediatric patients
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      3. context exact
        dicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
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        end exclusive
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        exact text
        aged 16 years and older with metastatic or locally advanced
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      4. context exact
        1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        81
        end exclusive
        true
        exact text
        methyltransferase inhibitor indicated for t
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      5. context exact
        Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
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        end exclusive
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        exact text
        metastatic or locally advanced epithelioid
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      6. context exact
        Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
        kind
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        202
        end exclusive
        true
        exact text
        metastatic or locally advanced epithelioid sa
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      regulatory links
      1. candidate source span
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
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        fda indication exact
        Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection
        fda source row index
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          follicular lymphoma (FL)
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        1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
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        Read indication-specific status → · whole_fda_indication_text_present

        Passage 2 · unclassified context
        application numbers
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        brand names
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        exact text
        ransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic thera
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        duplicate text group
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        generic names
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            source url
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                                  Read indication-specific status → · one_explicit_branch_of_combined_FDA_row_EZH2_positive

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                                    Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. Treatment of adult patients with R/R FL who have no satisfactory alternative treatment options
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                                    follicular lymphoma
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                                    true
                                    exact text
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                                    relapsed or refractory (R/R)
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                                  TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options.
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                                  regimen
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                                  Read indication-specific status → · one_explicit_branch_of_combined_FDA_row_no_satisfactory_alternative

                                  Passage 13 · approval contingency
                                  application numbers
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                                  brand names
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                                  -approved test and who have received at least 2 prior systemic therapies. TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )]. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                                      source defined aliases
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                                        FL
                                        definition exact
                                        follicular lymphoma
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                                        end
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                                        true
                                        exact text
                                        follicular lymphoma (FL)
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                                        exact text
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                                      These indications are approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.2 )].
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                                      biomarker and test
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                                      disease stage
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                                      limitations
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                                      prior therapy
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                                      Passage 14 · approval contingency
                                      application numbers
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                                            definition exact
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                                            end exclusive
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                                            exact text
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                                          Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                                          disease stage
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                                          limitations
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                                          Preserved source evidence · Not medical advice