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STATUS · fda-aa-ff0bb2ff50bfab679c37

Brukinsa (zanubrutinib)

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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

Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy

Source status category
ongoing
Event date
2024-03-07
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2024-03-07
accelerated approval date source text
3/7/2024
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-ff0bb2ff50bfab679c37
indication exact
Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
original projected completion source text
1/31/2029
post marketing requirement exact
4583-1: Complete a randomized clinical trial that evaluates the clinical benefit of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab in patients with relapsed or refractory FL. The primary endpoint should be PFS, with secondary endpoints that include ORR and OS. The trial should enroll a sufficiently representative study population that reflects the racial and ethnic diversity of the U.S. population of patients with FL and that allows for interpretation of the results in these populations.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma
source cells exact
  1. links
      text
      Brukinsa (zanubrutinib)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma
      text
      Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
    2. links
        text
        3/7/2024
      1. links
          text
          4583-1: Complete a randomized clinical trial that evaluates the clinical benefit of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab in patients with relapsed or refractory FL. The primary endpoint should be PFS, with secondary endpoints that include ORR and OS. The trial should enroll a sufficiently representative study population that reflects the racial and ethnic diversity of the U.S. population of patients with FL and that allows for interpretation of the results in these populations.
        1. links
            text
            1/31/2029
          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
          26
          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
          2024-03-07
          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-ff0bb2ff50bfab679c37
            indication exact
            Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-742003f289e5d88071fe
            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-3752e27dfd97ea222a2a81ad
              span id
              ind-span-742003f289e5d88071fe
              status id
              fda-aa-ff0bb2ff50bfab679c37
              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
              2736
              end exclusive
              true
              exact text
              1.5 Follicular Lymphoma BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
              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
              2522
              fda indication exact
              Adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
              fda source row index
              26
              fda source sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              fda status record id
              fda-aa-ff0bb2ff50bfab679c37
              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
              2024-03-07
              supporting anchor spans

              Preserved source evidence · Not medical advice