LABELS · 94544e08-d7c0-4154-aa40-46c5298c5528

FYARRO

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: 2026-05-19
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). ( 1 )

Full extracted label fields

application numbers

NDA213312

boxed warning exact

brand names

FYARRO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0f9bb784-53e2-46f9-a65d-1c6c2a230eaf

generic names

SIROLIMUS

94544e08-d7c0-4154-aa40-46c5298c5528

indications and usage exact

1 INDICATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Aadi Bioscience, Inc.

matched search terms

tumor
malignant

package ndcs

80803-153-50

product ndcs

80803-153

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2586863
2586868

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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: 500
total: 830

terms

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

sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2294544e08-d7c0-4154-aa40-46c5298c5528%22

spl effective date

2026-05-19

spl effective time

20260519

spl set id

0f9bb784-53e2-46f9-a65d-1c6c2a230eaf

spl version

substance names

SIROLIMUS

uniis

W36ZG6FT64

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

application number
NDA213312
payload
all indexed label documents
Appl No
213312
Application Docs Date
2021-12-10 00:00:00
Application Docs ID
69383
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213312Orig1s000Corrected_lbl.pdf
Submission No
1
Submission Type
ORIG
all submission records
Appl No
213312
Review Priority
PRIORITY
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2021-11-22 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
213312
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
14
Submission Status
AP
Submission Status Date
2026-09-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA213312
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=213312
has approved submission record
true
latest approved submission date
2026-09-02
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
213312
Application Docs Date
2021-12-10 00:00:00
Application Docs ID
69383
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213312Orig1s000Corrected_lbl.pdf
Submission No
1
Submission Type
ORIG
official application record
Appl No
213312
Appl Public Notes
Appl Type
NDA
Sponsor Name
AADI
openfda application present
true
products
Active Ingredient
SIROLIMUS
Appl No
213312
Drug Name
FYARRO
Form
POWDER;INTRAVENOUS
Product No
001
Reference Drug
1
Reference Standard
1
Strength
100MG/VIAL
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

NDA213312

brand names

FYARRO

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: 371
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). ( 1 )
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 0

current approval status

not_reconciled

duplicate text group

dup-107bee040928e3570f30

extraction review status

automated_candidate_pending_source_review

generic names

SIROLIMUS

ind-span-786cb1ce752cef324730

label id

94544e08-d7c0-4154-aa40-46c5298c5528

positive predicate support span

end: 45
end exclusive: true
exact text: is indicated
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 33

qualifier mentions

context exact
ATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant
kind
age
polarity
not_inferred
span
end
81
end exclusive
true
exact text
adult patients
label id
94544e08-d7c0-4154-aa40-46c5298c5528
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start
67
context exact
ent of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
kind
biomarker
polarity
not_inferred
span
end
163
end exclusive
true
exact text
metastatic malignant perivascular epithelio
label id
94544e08-d7c0-4154-aa40-46c5298c5528
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start
120
context exact
RRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
kind
stage_or_setting
polarity
not_inferred
span
end
138
end exclusive
true
exact text
locally advanced unresectable or metastatic maligna
label id
94544e08-d7c0-4154-aa40-46c5298c5528
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start
87

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 186
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2294544e08-d7c0-4154-aa40-46c5298c5528%22

spl effective date

2026-05-19

spl set id

0f9bb784-53e2-46f9-a65d-1c6c2a230eaf

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

NDA213312

brand names

FYARRO

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: 371
end exclusive: true
exact text: 1 INDICATIONS AND USAGE FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). ( 1 )
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 0

current approval status

not_reconciled

duplicate text group

dup-af84849bf3171751f75d

extraction review status

automated_candidate_pending_source_review

generic names

SIROLIMUS

ind-span-22b8780d387abec4037a

label id

94544e08-d7c0-4154-aa40-46c5298c5528

positive predicate support span

end: 224
end exclusive: true
exact text: is an mTOR inhibitor indicated
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 194

qualifier mentions

context exact
FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant
kind
age
polarity
not_inferred
span
end
260
end exclusive
true
exact text
adult patients
label id
94544e08-d7c0-4154-aa40-46c5298c5528
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start
246
context exact
ent of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
kind
biomarker
polarity
not_inferred
span
end
342
end exclusive
true
exact text
metastatic malignant perivascular epithelio
label id
94544e08-d7c0-4154-aa40-46c5298c5528
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start
299
context exact
nhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
kind
stage_or_setting
polarity
not_inferred
span
end
317
end exclusive
true
exact text
locally advanced unresectable or metastatic maligna
label id
94544e08-d7c0-4154-aa40-46c5298c5528
offset unit
unicode_code_points
source array index
0
source field
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source text sha256
b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start
266

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 365
end exclusive: true
exact text: FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 187

source url

https://api.fda.gov/drug/label.json?search=id%3A%2294544e08-d7c0-4154-aa40-46c5298c5528%22

spl effective date

2026-05-19

spl set id

0f9bb784-53e2-46f9-a65d-1c6c2a230eaf

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 3 · unclassified context

application numbers

NDA213312

brand names

FYARRO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 371
end exclusive: true
exact text: cell tumor (PEComa). FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). ( 1 )
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 166

current approval status

not_reconciled

duplicate text group

dup-a5302770cf6db0d5706d

extraction review status

automated_candidate_pending_source_review

generic names

SIROLIMUS

ind-span-84fbe3a38c6fb921249a

label id

94544e08-d7c0-4154-aa40-46c5298c5528

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

end: 371
end exclusive: true
exact text: ( 1 )
label id: 94544e08-d7c0-4154-aa40-46c5298c5528
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b5e0f402167573e34f29056e53bdac31b89aed075f0058ce3647096b6bd62264
start: 366

source url

https://api.fda.gov/drug/label.json?search=id%3A%2294544e08-d7c0-4154-aa40-46c5298c5528%22

spl effective date

2026-05-19

spl set id

0f9bb784-53e2-46f9-a65d-1c6c2a230eaf

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

unclear

Preserved source evidence · Not medical advice