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STATUS · fda-aa-6f710158e2a7014f682a

Tazverik (tazemetostat)

Open original source → · Download preserved record

This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection

Source status category
withdrawn
Event date
2026-06-22
Meaning of this date
FDA table withdrawal date
accelerated approval date
2020-01-23
accelerated approval date source text
1/23/2020
brand name hint
Tazverik
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Tazverik (tazemetostat)
generic name hint
tazemetostat
id
fda-aa-6f710158e2a7014f682a
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
original projected completion source text
Source null
post marketing requirement exact
Source null
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://wayback.archive-it.org/7993/20201222063544/https:/www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tazemetostat-advanced-epithelioid-sarcoma
source cells exact
  1. links
      text
      Tazverik (tazemetostat)
    1. text
      Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection
    2. links
        text
        1/23/2020
      1. links
          text
          6/22/2026
        source provenance
        bytes
        47132
        file
        /private/tmp/cancer-full-research/indications/raw/accelerated-withdrawn.html
        http status
        200
        retrieved at
        2026-09-09T23:35:14.026405+00:00
        sha256
        89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
        source page date Modified text
        Wed, 09/02/2026 - 00:00
        source page date Published text
        Wed, 09/02/2026 - 13:55
        source row index
        2
        source table headers
        1. Drug Name
        2. Accelerated Approval (AA) Indication
        3. Accelerated Approval Date
        4. Withdrawal Date 1
        source table index
        0
        source url
        https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
        status applies to
        This exact indication and regimen, not every use of this drug
        status category
        withdrawn
        status event date
        2026-06-22
        status event date meaning
        FDA table withdrawal date
        traditional approval date
        Source null
        verification flags
          verification status
          official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
          withdrawal date
          2026-06-22
          Source correspondence records
          matching
          drug name exact
          Tazverik (tazemetostat)
          fda status record id
          fda-aa-6f710158e2a7014f682a
          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
          match status
          source_correspondence_found_clinical_review_pending
          matched candidate ids
          1. ind-span-110aaafde7d28f7beecc
          2. ind-span-4d9ecea0e0ff7dc3fba7
          source provenance
          bytes
          47132
          file
          /private/tmp/cancer-full-research/indications/raw/accelerated-withdrawn.html
          http status
          200
          retrieved at
          2026-09-09T23:35:14.026405+00:00
          sha256
          89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
          source page date Modified text
          Wed, 09/02/2026 - 00:00
          source page date Published text
          Wed, 09/02/2026 - 13:55
          status category
          withdrawn
          unmatched meaning
          Source null
          links
          1. package id
            fda-label-library-8184721b7b3bb86692f8276c
            correspondence id
            correspondence-c268ae43280cc5a8e92cef6f
            span id
            ind-span-110aaafde7d28f7beecc
            status id
            fda-aa-6f710158e2a7014f682a
            match method
            whole_indication_literal_normalized_substring
            scope relationship
            whole_fda_indication_text_present
            matching review status
            source_comparison_only_clinical_review_pending
            payload
            candidate source span
            end
            244
            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.
            label id
            c4bd8d8a-22c1-4911-a9b4-7368582d8e5d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            18f5087946e80089ad976945ccf832834a6a6bfe8db1d4609ad98cc04e36669c
            start
            0
            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
            2
            fda source sha256
            89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
            fda status record id
            fda-aa-6f710158e2a7014f682a
            interpretation
            Potential stale-label conflict for this indication
            match method
            whole_indication_literal_normalized_substring
            matching review status
            source_comparison_only_clinical_review_pending
            scope relationship
            whole_fda_indication_text_present
            status category
            withdrawn
            status event date
            2026-06-22
            supporting anchor spans
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-cb3e2703a0b5d5ac41d9e991
              span id
              ind-span-4d9ecea0e0ff7dc3fba7
              status id
              fda-aa-6f710158e2a7014f682a
              match method
              whole_indication_literal_normalized_substring
              scope relationship
              whole_fda_indication_text_present
              matching review status
              source_comparison_only_clinical_review_pending
              payload
              candidate source span
              end
              1062
              end exclusive
              true
              exact text
              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.
              label id
              c4bd8d8a-22c1-4911-a9b4-7368582d8e5d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              18f5087946e80089ad976945ccf832834a6a6bfe8db1d4609ad98cc04e36669c
              start
              849
              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
              2
              fda source sha256
              89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
              fda status record id
              fda-aa-6f710158e2a7014f682a
              interpretation
              Potential stale-label conflict for this indication
              match method
              whole_indication_literal_normalized_substring
              matching review status
              source_comparison_only_clinical_review_pending
              scope relationship
              whole_fda_indication_text_present
              status category
              withdrawn
              status event date
              2026-06-22
              supporting anchor spans

              Preserved source evidence · Not medical advice