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STATUS · fda-aa-5ecb3872ea18a4986f48

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 mantle cell lymphoma (MCL) who have received at least one prior therapy.

Source status category
ongoing
Event date
2019-11-14
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2019-11-14
accelerated approval date source text
11/14/2019
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-5ecb3872ea18a4986f48
indication exact
Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
original projected completion source text
2/28/2027
post marketing requirement exact
3735-1: Complete and submit the final results of Trial BGB-3111-306 - the ongoing randomized, Phase 3 clinical trial of BRUKINSA in combination with rituximab versus bendamustine and rituximab in patients with previously untreated MCL. The primary endpoint is PFS as assessed by Independent Review Committee (IRC). OS is a key secondary endpoint. PFS and OS would be analyzed based on superiority testing. Enrollment of approximately 500 patients is expected
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 mantle cell lymphoma (MCL) who have received at least one prior therapy.
        1. links
            text
            11/14/2019
          1. links
              text
              3735-1: Complete and submit the final results of Trial BGB-3111-306 - the ongoing randomized, Phase 3 clinical trial of BRUKINSA in combination with rituximab versus bendamustine and rituximab in patients with previously untreated MCL. The primary endpoint is PFS as assessed by Independent Review Committee (IRC). OS is a key secondary endpoint. PFS and OS would be analyzed based on superiority testing. Enrollment of approximately 500 patients is expected
            1. links
                text
                2/28/2027
              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
              56
              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
              2019-11-14
              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-5ecb3872ea18a4986f48
                indication exact
                Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-3792ab1354fb3b74cb13
                2. ind-span-fdee0ace254430de56d6
                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-5412ef890935678cc1aa6086
                  span id
                  ind-span-3792ab1354fb3b74cb13
                  status id
                  fda-aa-5ecb3872ea18a4986f48
                  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
                  179
                  end exclusive
                  true
                  exact text
                  1 INDICATIONS AND USAGE BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior 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
                  0
                  fda indication exact
                  Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
                  fda source row index
                  56
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-5ecb3872ea18a4986f48
                  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
                  2019-11-14
                  supporting anchor spans
                  1. package id
                    fda-label-library-8184721b7b3bb86692f8276c
                    correspondence id
                    correspondence-71c0d96479811a6e941622f9
                    span id
                    ind-span-fdee0ace254430de56d6
                    status id
                    fda-aa-5ecb3872ea18a4986f48
                    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
                    1414
                    end exclusive
                    true
                    exact text
                    1.1 Mantle Cell Lymphoma BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior 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
                    1254
                    fda indication exact
                    Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
                    fda source row index
                    56
                    fda source sha256
                    8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                    fda status record id
                    fda-aa-5ecb3872ea18a4986f48
                    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
                    2019-11-14
                    supporting anchor spans

                    Preserved source evidence · Not medical advice