LABELS · aa4e8627-21c7-413a-9d0d-1957ded93283

CALQUENCE

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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: 2026-02-19
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 1.2 Previously Treated Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. 1.3 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Full extracted label fields

application numbers

NDA210259

boxed warning exact

brand names

CALQUENCE

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dd4835ef-e1bc-4997-a399-1ffa2556fbfe

generic names

ACALABRUTINIB

aa4e8627-21c7-413a-9d0d-1957ded93283

indications and usage exact

1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 1.2 Previously Treated Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. 1.3 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

indications and usage tables exact

is original packager

true

manufacturer names

AstraZeneca Pharmaceuticals LP

matched search terms

lymphoma
leukemia

package ndcs

0310-0512-60
0310-0512-28
0310-0512-95

product ndcs

0310-0512

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration, Recommended Dosage ( 2.1 ) 2/2026 Dosage and Administration, Dosage Modifications for Adverse Reactions ( 2.3 ) 2/2026 Warnings and Precautions, Serious and Opportunistic Infections ( 5.1 ) 2/2026

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

1986813
1986819

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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 · indication intro context

application numbers

NDA210259

brand names

CALQUENCE

classification reasons

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incomplete_colon_led_indication_intro

clinical review status

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content role

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exact text: 1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell tra
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current approval status

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extraction review status

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generic names

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qualifier mentions

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exact text: 1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated:
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source url

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spl effective date

2026-02-19

spl set id

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spl version

structured fields status

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structured indication

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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 2 · positive indication candidate

application numbers

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brand names

CALQUENCE

classification reasons

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clinical review status

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content role

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context span

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end exclusive: true
exact text: 1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lym
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extraction review status

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generic names

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exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
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exact text
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context exact
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exact text
In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoi
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exact text: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
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source url

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spl effective date

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spl set id

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structured indication

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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

tumor_directed_candidate

Passage 3 · unclassified context

application numbers

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brand names

CALQUENCE

classification reasons

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clinical review status

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exact text: h bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic
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generic names

ACALABRUTINIB

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label id

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positive predicate support span

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exact text: ( 1.1 )
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source url

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spl effective date

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spl version

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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

unclear

Passage 4 · positive indication candidate

application numbers

NDA210259

brand names

CALQUENCE

classification reasons

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clinical review status

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exact text: ustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combinati
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current approval status

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generic names

ACALABRUTINIB

ind-span-2b09525ace2c11cc2a66

label id

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exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
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source url

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tumor histology: Source null

use intent

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Passage 5 · unclassified context

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exact text: l lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with
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exact text: ( 1.2 )
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source url

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spl effective date

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Passage 6 · positive indication candidate

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exact text: ma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). ( 1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell l
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exact text: • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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source url

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spl effective date

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disease stage: Source null
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tumor histology: Source null

use intent

tumor_directed_candidate

Passage 7 · unclassified context

application numbers

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brand names

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exact text: ent of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma
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Preserved source evidence · Not medical advice