LABELS · 6c13a497-8849-4b37-a84d-692910963567

BEQALZI

Open original source → · Download preserved record

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: 2026-07-27
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. 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(s) [see Clinical Studies (14.1) ] . BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. ( 1 ) 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(s).

Full extracted label fields

application numbers

NDA220711

boxed warning exact

brand names

BEQALZI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff684558-e9cb-46de-a8bf-f4d79093df7a

generic names

SONROTOCLAX

6c13a497-8849-4b37-a84d-692910963567

indications and usage exact

1 INDICATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. 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(s) [see Clinical Studies (14.1) ] . BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. ( 1 ) 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(s).

indications and usage tables exact

is original packager

true

manufacturer names

BeOne Medicines USA, Inc.

matched search terms

lymphoma

package ndcs

72579-020-01
72579-017-01
72579-025-01
72579-025-02
72579-022-01
72579-022-08
72579-015-04
72579-020-04
72579-017-04
72579-025-04
72579-022-04

product ndcs

72579-015
72579-020
72579-017
72579-025
72579-022

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00400.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA220711

brand names

BEQALZI

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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exact text: 1 INDICATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. 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
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qualifier mentions

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CATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) afte
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context exact
QALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, includi
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exact text
relapsed or refractory mantle cell lymphoma
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exact text
after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor
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regulatory links

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exact text
1 INDICATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
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fda indication exact
Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
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5
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interpretation
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match method
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matching review status
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source url
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exact text: 1 INDICATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
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source url

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spl effective date

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structured indication

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biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Read indication-specific status → · whole_fda_indication_text_present

Passage 2 · approval contingency

application numbers

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brand names

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exact text: ndicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. 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(s) [see Clinical Studies (14.1) ] . BEQALZI is a BCL-2 inhibitor
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exact text: This indication is approved under accelerated approval based on response rate and durability of response.
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source url

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approval pathway: Source null
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disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 3 · approval contingency

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brand names

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exact text: at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. 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(s) [see Clinical Studies (14.1) ] . BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's ty
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exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) [see Clinical Studies (14.1) ] .
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source url

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structured indication

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tumor histology: Source null

use intent

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Passage 4 · positive indication candidate

application numbers

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exact text: and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) [see Clinical Studies (14.1) ] . BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. ( 1 ) 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 descript
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exact text
BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
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fda indication exact
Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
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Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · approval contingency

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Passage 6 · approval contingency

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Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef

source defined aliases

source span

end: 993
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 6c13a497-8849-4b37-a84d-692910963567
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 523d08a965fed1ec1d4141ebbf17d5b837ba3fc86800de9c1395b61cbef0e01f
start: 855

source url

https://api.fda.gov/drug/label.json?search=id%3A%226c13a497-8849-4b37-a84d-692910963567%22

spl effective date

2026-07-27

spl set id

ff684558-e9cb-46de-a8bf-f4d79093df7a

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice