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STATUS · fda-aa-3a92345d0c8c96b4af93

Brukinsa (zanubrutinib)

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 marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen

Source status category
ongoing
Event date
2021-09-14
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2021-09-14
accelerated approval date source text
9/14/2021
brand name hint
Brukinsa
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Brukinsa (zanubrutinib)
generic name hint
zanubrutinib
id
fda-aa-3a92345d0c8c96b4af93
indication exact
Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
original projected completion source text
10/31/2028
post marketing requirement exact
4128-1: Conduct a randomized clinical trial that verifies and describes the clinical benefit of zanubrutinib in patients with relapsed or refractory MZL. The trial should include sufficient representation of racial and ethnic minorities to better reflect the U.S. patient population and allow for interpretation of the results in these patient populations. The primary endpoint should be PFS, with secondary endpoints that include ORR and OS.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Brukinsa (zanubrutinib)
      1. links
          text
          Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
        1. links
            text
            9/14/2021
          1. links
              text
              4128-1: Conduct a randomized clinical trial that verifies and describes the clinical benefit of zanubrutinib in patients with relapsed or refractory MZL. The trial should include sufficient representation of racial and ethnic minorities to better reflect the U.S. patient population and allow for interpretation of the results in these patient populations. The primary endpoint should be PFS, with secondary endpoints that include ORR and OS.
            1. links
                text
                10/31/2028
              source provenance
              bytes
              102185
              file
              /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
              http status
              200
              retrieved at
              2026-09-09T23:35:15.160724+00:00
              sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              source page date Modified text
              Wed, 09/09/2026 - 00:00
              source page date Published text
              Wed, 09/09/2026 - 12:45
              source row index
              43
              source table headers
              1. Drug Name
              2. Accelerated Approval (AA) Indication
              3. AA Date
              4. AA Post-Marketing Requirement
              5. Original Projected Completion 1
              source table index
              0
              source url
              https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
              status applies to
              This exact indication and regimen, not every use of this drug
              status category
              ongoing
              status event date
              2021-09-14
              status event date meaning
              Original accelerated approval date; ongoing status observed at source retrieval
              traditional approval date
              Source null
              verification flags
                verification status
                official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
                withdrawal date
                Source null
                Source correspondence records
                matching
                drug name exact
                Brukinsa (zanubrutinib)
                fda status record id
                fda-aa-3a92345d0c8c96b4af93
                indication exact
                Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-e3d65d2168ac694257b1
                source provenance
                bytes
                102185
                file
                /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
                http status
                200
                retrieved at
                2026-09-09T23:35:15.160724+00:00
                sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                source page date Modified text
                Wed, 09/09/2026 - 00:00
                source page date Published text
                Wed, 09/09/2026 - 12:45
                status category
                ongoing
                unmatched meaning
                Source null
                links
                1. package id
                  fda-label-library-8184721b7b3bb86692f8276c
                  correspondence id
                  correspondence-ecd0597e10d22b177d07cb84
                  span id
                  ind-span-e3d65d2168ac694257b1
                  status id
                  fda-aa-3a92345d0c8c96b4af93
                  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
                  2036
                  end exclusive
                  true
                  exact text
                  1.3 Marginal Zone Lymphoma BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen.
                  label id
                  29341b77-7deb-445a-ae2c-a8e01c932daf
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  a86d0c49b0d5d59716847dd27bee57100417941b365c7f63fa7523059746ebac
                  start
                  1839
                  fda indication exact
                  Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
                  fda source row index
                  43
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-3a92345d0c8c96b4af93
                  interpretation
                  Source wording correspondence to a dated FDA status row; current approval not certified
                  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
                  ongoing
                  status event date
                  2021-09-14
                  supporting anchor spans

                  Preserved source evidence · Not medical advice