TriangleLABELS · 29341b77-7deb-445a-ae2c-a8e01c932daf
BRUKINSA
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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2026-07-21
- Captured
- 2026-09-09T23:37:42.544548+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source 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. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). ( 1.2 ) Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. ( 1.3 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.4 ) Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. ( 1.5 ) This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Waldenström's Macroglobulinemia BRUKINSA is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM) [see Clinical Studies (14.2) ] . 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. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.3) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.4 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [see Clinical Studies (14.4) ] . 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. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.5) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Full extracted label fields
- application numbers
- NDA213217
- NDA218785
- boxed warning exact
- brand names
- BRUKINSA
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3e08fe23-d70e-424c-bc51-1222e320f902
- generic names
- ZANUBRUTINIB
- id
- 29341b77-7deb-445a-ae2c-a8e01c932daf
- indications and usage exact
- 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. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Waldenström's macroglobulinemia (WM). ( 1.2 ) Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. ( 1.3 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.4 ) Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. ( 1.5 ) This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Waldenström's Macroglobulinemia BRUKINSA is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM) [see Clinical Studies (14.2) ] . 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. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.3) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.4 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [see Clinical Studies (14.4) ] . 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. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.5) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- BeOne Medicines USA, Inc.
- matched search terms
- lymphoma
- leukemia
- package ndcs
- 72579-011-02
- 72579-011-01
- 72579-122-01
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- 72579-122
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- record type
- complete_spl_indications_section_candidate
- routes
- ORAL
- rxcuis
- 2262440
- 2262446
- 2719220
- 2719223
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00100.json
- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
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Drugs@FDA application source records
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- NDA213217
- payload
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- Appl No
- 213217
- Application Docs Date
- 2019-11-14 00:00:00
- Application Docs ID
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- Submission No
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- Application Docs Date
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- Submission No
- 10
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- Application Docs Date
- 2023-12-21 00:00:00
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- 0
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- Application Docs Date
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- 2025-02-05 00:00:00
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- Appl No
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- Submission Type
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- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
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- official application record
- Appl No
- 213217
- Appl Public Notes
- Appl Type
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- Sponsor Name
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- openfda application present
- true
- products
- Active Ingredient
- ZANUBRUTINIB
- Appl No
- 213217
- Drug Name
- BRUKINSA
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- CAPSULE;ORAL
- Product No
- 001
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- 1
- Reference Standard
- 0
- Strength
- 80MG
- marketing status
- Discontinued
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- NDA218785
- payload
- all indexed label documents
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- 0
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- Submission Type
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- Application linkage and approved submission are not indication-level current approval verification
- current indication status
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- has approved submission record
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- official application record
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- Appl Public Notes
- Appl Type
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- Sponsor Name
- BEONE MEDICINES USA
- openfda application present
- true
- products
- Active Ingredient
- ZANUBRUTINIB
- Appl No
- 218785
- Drug Name
- BRUKINSA
- Form
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- Product No
- 001
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- Appl No
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- Drug Name
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- Form
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- Product No
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- Reference Drug
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- Reference Standard
- 0
- Strength
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- marketing status
- Prescription
Source passages and status connections
Passage 1 · positive indication candidate
- application numbers
- NDA213217
- NDA218785
- brand names
- BRUKINSA
- classification reasons
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- clinical review status
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- end exclusive
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- 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. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical b
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- qualifier mentions
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- UKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least
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- 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.
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- fda source row index
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- Source null
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- Source null
- line
- Source null
- prior therapy
- Source null
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- Source null
- tumor histology
- Source null
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Read indication-specific status → · whole_fda_indication_text_present
Passage 2 · approval contingency
- application numbers
- NDA213217
- NDA218785
- brand names
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Passage 10 · approval contingency
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Read indication-specific status → · whole_fda_indication_text_present
Passage 13 · approval contingency
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Passage 14 · approval contingency
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Read indication-specific status → · whole_fda_indication_text_present
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Read indication-specific status → · whole_fda_indication_text_present
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Preserved source evidence · Not medical advice