Skip to content
Triangle logo TriangleGet started
← Back to this collection

STATUS · fda-aa-2ba11c81701eb96d9675

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 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

Source status category
withdrawn
Event date
2026-06-22
Meaning of this date
FDA table withdrawal date
accelerated approval date
2020-06-18
accelerated approval date source text
6/18/2020
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-2ba11c81701eb96d9675
indication exact
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
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/7993/20201222062826/https:/www.fda.gov/drugs/fda-granted-accelerated-approval-tazemetostat-follicular-lymphoma
source cells exact
  1. links
      text
      Tazverik (tazemetostat)
    1. text
      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
    2. links
        text
        6/18/2020
      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        /private/tmp/cancer-full-research/indications/raw/accelerated-withdrawn.html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
        3
        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-2ba11c81701eb96d9675
          indication exact
          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
          match status
          source_correspondence_found_clinical_review_pending
          matched candidate ids
          1. ind-span-e20dbd0ca71b3d9dbd0a
          2. ind-span-7d8e4fe5ae4a7af9723d
          3. ind-span-f3ffe02f8e1ecf4de73f
          4. ind-span-61f2511ee0e370298bfc
          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-1ce866f1e54d86e802b3a4f7
            span id
            ind-span-f3ffe02f8e1ecf4de73f
            status id
            fda-aa-2ba11c81701eb96d9675
            match method
            targeted_literal_constraint_correspondence
            scope relationship
            one_explicit_branch_of_combined_FDA_row_EZH2_positive
            matching review status
            source_comparison_only_clinical_review_pending
            payload
            candidate source span
            end
            1651
            end exclusive
            true
            exact text
            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.
            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
            1346
            fda indication exact
            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
            fda source row index
            3
            fda source sha256
            89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
            fda status record id
            fda-aa-2ba11c81701eb96d9675
            interpretation
            Potential stale-label conflict for this indication
            match method
            targeted_literal_constraint_correspondence
            matching review status
            source_comparison_only_clinical_review_pending
            scope relationship
            one_explicit_branch_of_combined_FDA_row_EZH2_positive
            status category
            withdrawn
            status event date
            2026-06-22
            supporting anchor spans
            1. end
              1450
              end exclusive
              true
              exact text
              adult patients
              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
              1436
            2. end
              1372
              end exclusive
              true
              exact text
              Relapsed or Refractory
              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
              1350
            3. end
              1392
              end exclusive
              true
              exact text
              Follicular Lymphoma
              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
              1373
            4. end
              1556
              end exclusive
              true
              exact text
              EZH2 mutation
              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
              1543
            5. end
              1592
              end exclusive
              true
              exact text
              FDA-approved test
              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
              1575
            6. end
              1650
              end exclusive
              true
              exact text
              at least 2 prior systemic therapies
              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
              1615
          2. package id
            fda-label-library-8184721b7b3bb86692f8276c
            correspondence id
            correspondence-420f6bde087eb93d09e5a34e
            span id
            ind-span-e20dbd0ca71b3d9dbd0a
            status id
            fda-aa-2ba11c81701eb96d9675
            match method
            targeted_literal_constraint_correspondence
            scope relationship
            one_explicit_branch_of_combined_FDA_row_EZH2_positive
            matching review status
            source_comparison_only_clinical_review_pending
            payload
            candidate source span
            end
            457
            end exclusive
            true
            exact text
            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.
            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
            253
            fda indication exact
            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
            fda source row index
            3
            fda source sha256
            89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
            fda status record id
            fda-aa-2ba11c81701eb96d9675
            interpretation
            Potential stale-label conflict for this indication
            match method
            targeted_literal_constraint_correspondence
            matching review status
            source_comparison_only_clinical_review_pending
            scope relationship
            one_explicit_branch_of_combined_FDA_row_EZH2_positive
            status category
            withdrawn
            status event date
            2026-06-22
            supporting anchor spans
            1. end
              267
              end exclusive
              true
              exact text
              Adult patients
              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
              253
            2. end
              295
              end exclusive
              true
              exact text
              relapsed or refractory
              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
              273
            3. end
              315
              end exclusive
              true
              exact text
              follicular lymphoma
              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
              296
            4. end
              362
              end exclusive
              true
              exact text
              EZH2 mutation
              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
              349
            5. end
              398
              end exclusive
              true
              exact text
              FDA-approved test
              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
              381
            6. end
              456
              end exclusive
              true
              exact text
              at least 2 prior systemic therapies
              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
              421
          3. package id
            fda-label-library-8184721b7b3bb86692f8276c
            correspondence id
            correspondence-471919fb530c7c77149b92d7
            span id
            ind-span-61f2511ee0e370298bfc
            status id
            fda-aa-2ba11c81701eb96d9675
            match method
            targeted_literal_constraint_correspondence
            scope relationship
            one_explicit_branch_of_combined_FDA_row_no_satisfactory_alternative
            matching review status
            source_comparison_only_clinical_review_pending
            payload
            candidate source span
            end
            1777
            end exclusive
            true
            exact text
            TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options.
            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
            1652
            fda indication exact
            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
            fda source row index
            3
            fda source sha256
            89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
            fda status record id
            fda-aa-2ba11c81701eb96d9675
            interpretation
            Potential stale-label conflict for this indication
            match method
            targeted_literal_constraint_correspondence
            matching review status
            source_comparison_only_clinical_review_pending
            scope relationship
            one_explicit_branch_of_combined_FDA_row_no_satisfactory_alternative
            status category
            withdrawn
            status event date
            2026-06-22
            supporting anchor spans
            1. end
              1709
              end exclusive
              true
              exact text
              adult patients
              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
              1695
            2. end
              1721
              end exclusive
              true
              exact text
              FL
              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
              1719
            3. end
              1718
              end exclusive
              true
              exact text
              R/R
              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
              1715
            4. end
              1776
              end exclusive
              true
              exact text
              no satisfactory alternative treatment options
              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
              1731
            5. end
              1509
              end exclusive
              true
              exact text
              follicular lymphoma (FL)
              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
              1485
            6. end
              1484
              end exclusive
              true
              exact text
              relapsed or refractory (R/R)
              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
              1456
          4. package id
            fda-label-library-8184721b7b3bb86692f8276c
            correspondence id
            correspondence-fcaa9b464df83ea9d4f3b01f
            span id
            ind-span-7d8e4fe5ae4a7af9723d
            status id
            fda-aa-2ba11c81701eb96d9675
            match method
            targeted_literal_constraint_correspondence
            scope relationship
            one_explicit_branch_of_combined_FDA_row_no_satisfactory_alternative
            matching review status
            source_comparison_only_clinical_review_pending
            payload
            candidate source span
            end
            584
            end exclusive
            true
            exact text
            Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
            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
            466
            fda indication exact
            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
            fda source row index
            3
            fda source sha256
            89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
            fda status record id
            fda-aa-2ba11c81701eb96d9675
            interpretation
            Potential stale-label conflict for this indication
            match method
            targeted_literal_constraint_correspondence
            matching review status
            source_comparison_only_clinical_review_pending
            scope relationship
            one_explicit_branch_of_combined_FDA_row_no_satisfactory_alternative
            status category
            withdrawn
            status event date
            2026-06-22
            supporting anchor spans
            1. end
              480
              end exclusive
              true
              exact text
              Adult patients
              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
              466
            2. end
              528
              end exclusive
              true
              exact text
              follicular lymphoma
              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
              509
            3. end
              508
              end exclusive
              true
              exact text
              relapsed or refractory
              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
              486
            4. end
              583
              end exclusive
              true
              exact text
              no satisfactory alternative treatment options
              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
              538

          Preserved source evidence · Not medical advice