LABELS · 1c261eb0-f426-47a1-8281-62282d207644

JAKAFI

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: 2026-07-20
Captured: 2026-09-09T23:37:39.774134+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 ) 1.1 Myelofibrosis JAKAFI/JAKAFI XR is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults. 1.2 Polycythemia Vera JAKAFI/JAKAFI XR is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. 1.3 Acute Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older. 1.4 Chronic Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Full extracted label fields

application numbers

NDA202192
NDA217180

boxed warning exact

brand names

JAKAFI
JAKAFI XR

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1c82580-87ae-11e0-bc84-0002a5d5c51b

generic names

RUXOLITINIB

1c261eb0-f426-47a1-8281-62282d207644

indications and usage exact

1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 ) 1.1 Myelofibrosis JAKAFI/JAKAFI XR is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF in adults. 1.2 Polycythemia Vera JAKAFI/JAKAFI XR is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. 1.3 Acute Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older. 1.4 Chronic Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

indications and usage tables exact

is original packager

true

manufacturer names

Incyte Corporation

matched search terms

myelofibrosis
polycythemia
thrombocythemia

package ndcs

50881-005-60
50881-010-01
50881-010-60
50881-015-60
50881-020-60
50881-025-60
50881-011-08
50881-022-08
50881-033-08
50881-044-08
50881-055-08

product ndcs

50881-005
50881-010
50881-015
50881-020
50881-025
50881-011
50881-022
50881-033
50881-044
50881-055

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

kjhkj bnvv Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 05/2026

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

1193331
1193337
1193339
1193341
1193343
1193345
1193347
1193349
1193351
1193353
2743012
2743016

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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

license

https://open.fda.gov/license/

results

limit: 100
skip: 0
total: 830

terms

https://open.fda.gov/terms/

sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%221c261eb0-f426-47a1-8281-62282d207644%22

spl effective date

2026-07-20

spl effective time

20260720

spl set id

f1c82580-87ae-11e0-bc84-0002a5d5c51b

spl version

substance names

RUXOLITINIB

uniis

82S8X8XX8H

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA202192
payload
all indexed label documents
Appl No
202192
Application Docs Date
2011-11-16 00:00:00
Application Docs ID
19078
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
202192
Application Docs Date
2013-06-18 00:00:00
Application Docs ID
19079
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2014-07-28 00:00:00
Application Docs ID
19080
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2014-12-04 00:00:00
Application Docs ID
19292
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf
Submission No
8
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2016-03-15 00:00:00
Application Docs ID
19293
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2012-06-22 00:00:00
Application Docs ID
40135
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2013-11-26 00:00:00
Application Docs ID
40136
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2014-12-16 00:00:00
Application Docs ID
40137
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2017-10-11 00:00:00
Application Docs ID
50006
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf
Submission No
14
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2017-12-12 00:00:00
Application Docs ID
50665
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf
Submission No
15
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2018-10-30 00:00:00
Application Docs ID
56165
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
202192
Application Docs Date
2019-05-24 00:00:00
Application Docs ID
58862
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf
Submission No
17
Submission Type
SUPPL
all submission records
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
33
Submission Status
AP
Submission Status Date
2026-07-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
28
Submission Status
AP
Submission Status Date
2023-01-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
27
Submission Status
AP
Submission Status Date
2022-12-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
25
Submission Status
AP
Submission Status Date
2021-09-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
23
Submission Status
AP
Submission Status Date
2021-09-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
19
Submission Status
AP
Submission Status Date
2020-01-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
17
Submission Status
AP
Submission Status Date
2019-05-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
16
Submission Status
AP
Submission Status Date
2018-10-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
15
Submission Status
AP
Submission Status Date
2017-12-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
14
Submission Status
AP
Submission Status Date
2017-10-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
12
Submission Status
AP
Submission Status Date
2016-03-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
202192
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
11
Submission Status
AP
Submission Status Date
2015-10-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA202192
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202192
has approved submission record
true
latest approved submission date
2026-07-20
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
202192
Application Docs Date
2026-07-30 00:00:00
Application Docs ID
86743
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202192s033lbl.pdf
Submission No
33
Submission Type
SUPPL
official application record
Appl No
202192
Appl Public Notes
Appl Type
NDA
Sponsor Name
INCYTE CORP
openfda application present
true
products
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
202192
Drug Name
JAKAFI
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 5MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
202192
Drug Name
JAKAFI
Form
TABLET;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
EQ 10MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
202192
Drug Name
JAKAFI
Form
TABLET;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
EQ 15MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
202192
Drug Name
JAKAFI
Form
TABLET;ORAL
Product No
004
Reference Drug
1
Reference Standard
0
Strength
EQ 20MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
202192
Drug Name
JAKAFI
Form
TABLET;ORAL
Product No
005
Reference Drug
1
Reference Standard
1
Strength
EQ 25MG BASE
marketing status
Prescription
application number
NDA217180
payload
all indexed label documents
Appl No
217180
Application Docs Date
2026-05-05 00:00:00
Application Docs ID
85837
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217180Orig1s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
217180
Application Docs Date
2026-07-30 00:00:00
Application Docs ID
86746
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217180s001lbl.pdf
Submission No
1
Submission Type
SUPPL
all submission records
Appl No
217180
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2026-05-01 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
217180
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2026-07-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA217180
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217180
has approved submission record
true
latest approved submission date
2026-07-20
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
217180
Application Docs Date
2026-07-30 00:00:00
Application Docs ID
86746
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217180s001lbl.pdf
Submission No
1
Submission Type
SUPPL
official application record
Appl No
217180
Appl Public Notes
Appl Type
NDA
Sponsor Name
INCYTE CORP
openfda application present
true
products
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
217180
Drug Name
JAKAFI XR
Form
TABLET, EXTENDED RELEASE;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 11MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
217180
Drug Name
JAKAFI XR
Form
TABLET, EXTENDED RELEASE;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
EQ 22MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
217180
Drug Name
JAKAFI XR
Form
TABLET, EXTENDED RELEASE;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
EQ 33MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
217180
Drug Name
JAKAFI XR
Form
TABLET, EXTENDED RELEASE;ORAL
Product No
004
Reference Drug
1
Reference Standard
0
Strength
EQ 44MG BASE
marketing status
Prescription
Active Ingredient
RUXOLITINIB PHOSPHATE
Appl No
217180
Drug Name
JAKAFI XR
Form
TABLET, EXTENDED RELEASE;ORAL
Product No
005
Reference Drug
1
Reference Standard
1
Strength
EQ 55MG BASE
marketing status
Prescription

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

NDA202192
NDA217180

brand names

JAKAFI
JAKAFI XR

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 462
end exclusive: true
exact text: 1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients
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source text sha256: 84efe9c3008f620ba0167cffdd50a6a9ba4aeda96d640fc94642f4d6e6ee93ba
start: 0

current approval status

not_reconciled

duplicate text group

dup-aea70700bea15966fd8e

extraction review status

automated_candidate_pending_source_review

generic names

RUXOLITINIB

ind-span-0e5afdea8e825a614cbb

label id

1c261eb0-f426-47a1-8281-62282d207644

positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
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offset unit: unicode_code_points
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source field: indications_and_usage_exact
source text sha256: 84efe9c3008f620ba0167cffdd50a6a9ba4aeda96d640fc94642f4d6e6ee93ba
start: 41

qualifier mentions

context exact
brosis, and post-essential thrombocythemia myelofibrosis in adults.
kind
age
polarity
not_inferred
span
end
261
end exclusive
true
exact text
adults
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source text sha256
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start
255

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 262
end exclusive: true
exact text: 1 INDICATIONS AND USAGE JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults.
label id: 1c261eb0-f426-47a1-8281-62282d207644
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 84efe9c3008f620ba0167cffdd50a6a9ba4aeda96d640fc94642f4d6e6ee93ba
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%221c261eb0-f426-47a1-8281-62282d207644%22

spl effective date

2026-07-20

spl set id

f1c82580-87ae-11e0-bc84-0002a5d5c51b

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

tumor_directed_candidate

Passage 2 · positive indication candidate

application numbers

NDA202192
NDA217180

brand names

JAKAFI
JAKAFI XR

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 571
end exclusive: true
exact text: indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic
label id: 1c261eb0-f426-47a1-8281-62282d207644
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 84efe9c3008f620ba0167cffdd50a6a9ba4aeda96d640fc94642f4d6e6ee93ba
start: 63

current approval status

not_reconciled

duplicate text group

dup-6134bcca452f80714d47

extraction review status

automated_candidate_pending_source_review

generic names

RUXOLITINIB

ind-span-b3fb3772458c8b002ffa

label id

1c261eb0-f426-47a1-8281-62282d207644

positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
label id: 1c261eb0-f426-47a1-8281-62282d207644
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source field: indications_and_usage_exact
source text sha256: 84efe9c3008f620ba0167cffdd50a6a9ba4aeda96d640fc94642f4d6e6ee93ba
start: 41

qualifier mentions

context exact
( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of
kind
age
polarity
not_inferred
span
end
298
end exclusive
true
exact text
adults
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source array index
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source field
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exact text: 1.2 Polycythemia Vera JAKAFI/JAKAFI XR is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
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versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
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ease JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
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regulatory links

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source batch sha256

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source defined aliases

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exact text: 1.3 Acute Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%221c261eb0-f426-47a1-8281-62282d207644%22

spl effective date

2026-07-20

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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

non_oncology_or_unclear_candidate

Passage 9 · positive indication candidate

application numbers

NDA202192
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brand names

JAKAFI
JAKAFI XR

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clinical review status

pending

content role

positive_indication_candidate

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exact text: urea. 1.3 Acute Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older. 1.4 Chronic Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
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qualifier mentions

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D) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
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ailure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
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o lines of systemic therapy in adult and pediatric patients 12 years and older.
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regulatory links

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source defined aliases

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exact text: 1.4 Chronic Graft-Versus-Host Disease JAKAFI/JAKAFI XR is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%221c261eb0-f426-47a1-8281-62282d207644%22

spl effective date

2026-07-20

spl set id

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spl version

structured fields status

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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

non_oncology_or_unclear_candidate

Preserved source evidence · Not medical advice