LABELS · e187165a-eb84-4ee5-98b8-d4e777ec7b4a

SCEMBLIX

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: 2025-11-25
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )

Full extracted label fields

application numbers

NDA215358

boxed warning exact

brand names

SCEMBLIX

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e33001e7-3650-42b1-ae56-cddb5c43aa2b

generic names

ASCIMINIB

e187165a-eb84-4ee5-98b8-d4e777ec7b4a

indications and usage exact

1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Novartis Pharmaceuticals Corporation

matched search terms

leukemia

package ndcs

0078-1091-20
0078-1091-94
0078-1098-20
0078-1098-05
0078-1098-30
0078-1098-94
0078-1196-20

product ndcs

0078-1091
0078-1098
0078-1196

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2584320
2584326
2584328
2584330
2680278
2680280

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.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: 700
total: 830

terms

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

sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e187165a-eb84-4ee5-98b8-d4e777ec7b4a%22

spl effective date

2025-11-25

spl effective time

20251125

spl set id

e33001e7-3650-42b1-ae56-cddb5c43aa2b

spl version

substance names

ASCIMINIB HYDROCHLORIDE

uniis

C5U34S9XFV

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
NDA215358
payload
all indexed label documents
Appl No
215358
Application Docs Date
2021-10-29 00:00:00
Application Docs ID
69162
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
215358
Application Docs Date
2021-10-29 00:00:00
Application Docs ID
69163
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig2lbl.pdf
Submission No
2
Submission Type
ORIG
Appl No
215358
Application Docs Date
2022-10-13 00:00:00
Application Docs ID
72321
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215358s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2023-06-27 00:00:00
Application Docs ID
74629
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215358s003lbl.pdf
Submission No
3
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2023-11-09 00:00:00
Application Docs ID
76543
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215358s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2024-08-08 00:00:00
Application Docs ID
79343
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358s007lbl.pdf
Submission No
7
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2024-10-29 00:00:00
Application Docs ID
80040
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2024-10-29 00:00:00
Application Docs ID
80890
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2025-10-03 00:00:00
Application Docs ID
83648
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215358s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2025-11-28 00:00:00
Application Docs ID
84339
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215358s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
215358
Application Docs Date
2026-08-24 00:00:00
Application Docs ID
87016
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215358Orig1s014lbl.pdf
Submission No
14
Submission Type
SUPPL
all submission records
Appl No
215358
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2021-10-29 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
215358
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
1
Submission Status
AP
Submission Status Date
2022-10-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
2
Submission Status
AP
Submission Status Date
2021-10-29 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
215358
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
3
Submission Status
AP
Submission Status Date
2023-06-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
4
Submission Status
AP
Submission Status Date
2023-11-08 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
5
Submission Status
AP
Submission Status Date
2024-06-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
2024-08-07 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
8
Submission Status
AP
Submission Status Date
2024-10-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
9
Submission Status
AP
Submission Status Date
2024-10-29 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
10
Submission Status
AP
Submission Status Date
2025-10-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
12
Submission Status
AP
Submission Status Date
2025-11-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
215358
Review Priority
N/A
Submission Class Code ID
4
Submission No
14
Submission Status
AP
Submission Status Date
2026-04-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA215358
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=215358
has approved submission record
true
latest approved submission date
2026-04-14
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
215358
Application Docs Date
2026-08-24 00:00:00
Application Docs ID
87016
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215358Orig1s014lbl.pdf
Submission No
14
Submission Type
SUPPL
official application record
Appl No
215358
Appl Public Notes
Appl Type
NDA
Sponsor Name
NOVARTIS
openfda application present
true
products
Active Ingredient
ASCIMINIB HYDROCHLORIDE
Appl No
215358
Drug Name
SCEMBLIX
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 20MG BASE
marketing status
Prescription
Active Ingredient
ASCIMINIB HYDROCHLORIDE
Appl No
215358
Drug Name
SCEMBLIX
Form
TABLET;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
EQ 40MG BASE
marketing status
Prescription
Active Ingredient
ASCIMINIB HYDROCHLORIDE
Appl No
215358
Drug Name
SCEMBLIX
Form
TABLET;ORAL
Product No
003
Reference Drug
1
Reference Standard
1
Strength
EQ 100MG 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

NDA215358

brand names

SCEMBLIX

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: 394
end exclusive: true
exact text: 1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verificatio
label id: e187165a-eb84-4ee5-98b8-d4e777ec7b4a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 0

current approval status

not_reconciled

duplicate text group

dup-679c0705d97755162566

extraction review status

automated_candidate_pending_source_review

generic names

ASCIMINIB

ind-span-0b7adb8b1f6b549ba855

label id

e187165a-eb84-4ee5-98b8-d4e777ec7b4a

positive predicate support span

end: 45
end exclusive: true
exact text: is indicated
label id: e187165a-eb84-4ee5-98b8-d4e777ec7b4a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 33

qualifier mentions

context exact
ATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chro
kind
age
polarity
not_inferred
span
end
81
end exclusive
true
exact text
adult patients
label id
e187165a-eb84-4ee5-98b8-d4e777ec7b4a
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start
67

regulatory links

candidate source span
end
194
end exclusive
true
exact text
1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
label id
e187165a-eb84-4ee5-98b8-d4e777ec7b4a
offset unit
unicode_code_points
source array index
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source field
indications_and_usage_exact
source text sha256
8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start
0
fda indication exact
Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
fda source row index
19
fda source sha256
8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
fda status record id
fda-aa-f95ec17446197e3c8811
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
source url
https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
status category
ongoing
status event date
2024-10-29
supporting anchor spans

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

source span

end: 194
end exclusive: true
exact text: 1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
label id: e187165a-eb84-4ee5-98b8-d4e777ec7b4a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e187165a-eb84-4ee5-98b8-d4e777ec7b4a%22

spl effective date

2025-11-25

spl set id

e33001e7-3650-42b1-ae56-cddb5c43aa2b

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

Read indication-specific status → · whole_fda_indication_text_present

Passage 2 · approval contingency

application numbers

NDA215358

brand names

SCEMBLIX

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 520
end exclusive: true
exact text: 1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCE
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 0

current approval status

not_reconciled

duplicate text group

dup-dd1a96ac1c16b1c58f71

extraction review status

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generic names

ASCIMINIB

ind-span-9312f2446d1e4464bdb8

label id

e187165a-eb84-4ee5-98b8-d4e777ec7b4a

positive predicate support span

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qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

source span

end: 320
end exclusive: true
exact text: This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] .
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source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 195

source url

https://api.fda.gov/drug/label.json?search=id%3A%22e187165a-eb84-4ee5-98b8-d4e777ec7b4a%22

spl effective date

2025-11-25

spl set id

e33001e7-3650-42b1-ae56-cddb5c43aa2b

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

not_applicable

Passage 3 · approval contingency

application numbers

NDA215358

brand names

SCEMBLIX

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 643
end exclusive: true
exact text: mosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-pos
label id: e187165a-eb84-4ee5-98b8-d4e777ec7b4a
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source array index: 0
source field: indications_and_usage_exact
source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 121

current approval status

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dup-d67427345d2a1974cad0

extraction review status

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generic names

ASCIMINIB

ind-span-7b87bc5d0d6a7b95e7d6

label id

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positive predicate support span

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qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

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end: 443
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exact text: Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22e187165a-eb84-4ee5-98b8-d4e777ec7b4a%22

spl effective date

2025-11-25

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

not_applicable

Passage 4 · unclassified context

application numbers

NDA215358

brand names

SCEMBLIX

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 677
end exclusive: true
exact text: roval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph
label id: e187165a-eb84-4ee5-98b8-d4e777ec7b4a
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
start: 244

current approval status

not_reconciled

duplicate text group

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extraction review status

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generic names

ASCIMINIB

ind-span-75be42896c5b52fbc8e4

label id

e187165a-eb84-4ee5-98b8-d4e777ec7b4a

positive predicate support span

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qualifier mentions

context exact
Previously treated Ph+ CML in CP.
kind
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end
476
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exact text
Previously treated Ph+ CML in CP
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Read indication-specific status → · whole_fda_indication_text_present

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Passage 11 · unclassified context

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Preserved source evidence · Not medical advice