LABELS · 5b9e7961-f843-49d8-94b5-a2ce2c9efa46

VITRAKVI

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: 2018-12-05
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials ( 1 , 14 ).

Full extracted label fields

application numbers

NDA210861
NDA211710

boxed warning exact

brand names

VITRAKVI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9525f887-a055-4e33-8e92-898d42828cd1

generic names

LAROTRECTINIB

5b9e7961-f843-49d8-94b5-a2ce2c9efa46

indications and usage exact

1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials ( 1 , 14 ).

indications and usage tables exact

is original packager

true

manufacturer names

Loxo Oncology, Inc.

matched search terms

tumors

package ndcs

71777-390-01
71777-391-01
71777-392-01

product ndcs

71777-390
71777-391
71777-392

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2105633
2105645
2105649
2105653
2105655
2105657

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.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: 300
total: 830

terms

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

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b9e7961-f843-49d8-94b5-a2ce2c9efa46%22

spl effective date

2018-12-05

spl effective time

20181205

spl set id

9525f887-a055-4e33-8e92-898d42828cd1

spl version

substance names

LAROTRECTINIB

uniis

PF9462I9HX

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
NDA210861
payload
all indexed label documents
Appl No
210861
Application Docs Date
2018-11-26 00:00:00
Application Docs ID
56563
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
210861
Application Docs Date
2021-03-26 00:00:00
Application Docs ID
66886
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210861s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
210861
Application Docs Date
2022-11-28 00:00:00
Application Docs ID
72727
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210861s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
210861
Application Docs Date
2023-11-06 00:00:00
Application Docs ID
76385
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210861s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
210861
Application Docs Date
2025-04-25 00:00:00
Application Docs ID
82012
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf
Submission No
12
Submission Type
SUPPL
all submission records
Appl No
210861
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
12
Submission Status
AP
Submission Status Date
2025-04-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210861
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2023-11-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210861
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2022-11-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210861
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2021-03-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210861
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
4
Submission Status
AP
Submission Status Date
2021-03-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
210861
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2018-11-26 00:00:00
Submission Type
ORIG
Submissions Public Notes
application number
NDA210861
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=210861
has approved submission record
true
latest approved submission date
2025-04-09
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
210861
Application Docs Date
2025-04-25 00:00:00
Application Docs ID
82012
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf
Submission No
12
Submission Type
SUPPL
official application record
Appl No
210861
Appl Public Notes
Appl Type
NDA
Sponsor Name
BAYER HLTHCARE
openfda application present
true
products
Active Ingredient
LAROTRECTINIB SULFATE
Appl No
210861
Drug Name
VITRAKVI
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
0
Strength
EQ 25MG BASE
marketing status
Prescription
Active Ingredient
LAROTRECTINIB SULFATE
Appl No
210861
Drug Name
VITRAKVI
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
1
Strength
EQ 100MG BASE
marketing status
Prescription
application number
NDA211710
payload
all indexed label documents
Appl No
211710
Application Docs Date
2018-11-26 00:00:00
Application Docs ID
56562
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
211710
Application Docs Date
2021-03-26 00:00:00
Application Docs ID
66885
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
211710
Application Docs Date
2021-03-26 00:00:00
Application Docs ID
66887
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
211710
Application Docs Date
2022-11-28 00:00:00
Application Docs ID
72728
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211710s008lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
211710
Application Docs Date
2023-11-06 00:00:00
Application Docs ID
76369
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211710s009lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
211710
Application Docs Date
2025-04-25 00:00:00
Application Docs ID
82013
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211710s010lbl.pdf
Submission No
10
Submission Type
SUPPL
all submission records
Appl No
211710
Review Priority
PRIORITY
Submission Class Code ID
12
Submission No
1
Submission Status
AP
Submission Status Date
2018-11-26 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
211710
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
4
Submission Status
AP
Submission Status Date
2021-03-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
211710
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
5
Submission Status
AP
Submission Status Date
2021-03-25 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
211710
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
8
Submission Status
AP
Submission Status Date
2022-11-23 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
211710
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
9
Submission Status
AP
Submission Status Date
2023-11-03 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
211710
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
10
Submission Status
AP
Submission Status Date
2025-04-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA211710
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=211710
has approved submission record
true
latest approved submission date
2025-04-09
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
211710
Application Docs Date
2025-04-25 00:00:00
Application Docs ID
82013
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211710s010lbl.pdf
Submission No
10
Submission Type
SUPPL
official application record
Appl No
211710
Appl Public Notes
Appl Type
NDA
Sponsor Name
BAYER HEALTHCARE
openfda application present
true
products
Active Ingredient
LAROTRECTINIB SULFATE
Appl No
211710
Drug Name
VITRAKVI
Form
SOLUTION;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 20MG BASE/ML
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

NDA210861
NDA211710

brand names

VITRAKVI

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: 319
end exclusive: true
exact text: 1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity,
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 0

current approval status

not_reconciled

duplicate text group

dup-cd3ba4b0b3f7381d975b

extraction review status

automated_candidate_pending_source_review

generic names

LAROTRECTINIB

ind-span-56ca1fd068d50e6efbc5

label id

5b9e7961-f843-49d8-94b5-a2ce2c9efa46

positive predicate support span

end: 45
end exclusive: true
exact text: is indicated
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 33

qualifier mentions

context exact
ATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:
kind
age
polarity
not_inferred
span
end
72
end exclusive
true
exact text
adult
label id
5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
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start
67
context exact
USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:
kind
age
polarity
not_inferred
span
end
95
end exclusive
true
exact text
pediatric patients
label id
5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start
77

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 119
end exclusive: true
exact text: 1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b9e7961-f843-49d8-94b5-a2ce2c9efa46%22

spl effective date

2018-12-05

spl set id

9525f887-a055-4e33-8e92-898d42828cd1

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 · unclassified context

application numbers

NDA210861
NDA211710

brand names

VITRAKVI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 433
end exclusive: true
exact text: 1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 0

current approval status

not_reconciled

duplicate text group

dup-3896ba8f4b33fe81f22b

extraction review status

automated_candidate_pending_source_review

generic names

LAROTRECTINIB

ind-span-42c465968bf2a505897c

label id

5b9e7961-f843-49d8-94b5-a2ce2c9efa46

positive predicate support span

Source null

qualifier mentions

context exact
• have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation,
kind
biomarker
polarity
not_inferred
span
end
213
end exclusive
true
exact text
NTRK ) gene fusion without a known acquired
label id
5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start
169

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 233
end exclusive: true
exact text: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation,
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 120

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b9e7961-f843-49d8-94b5-a2ce2c9efa46%22

spl effective date

2018-12-05

spl set id

9525f887-a055-4e33-8e92-898d42828cd1

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

Passage 3 · unclassified context

application numbers

NDA210861
NDA211710

brand names

VITRAKVI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 523
end exclusive: true
exact text: s indicated for the treatment of adult and pediatric patients with solid tumors that: • have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of respon
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 34

current approval status

not_reconciled

duplicate text group

dup-76a9583a1f73b5eeebbb

extraction review status

automated_candidate_pending_source_review

generic names

LAROTRECTINIB

ind-span-7f8f13a9f7c68d8dd35c

label id

5b9e7961-f843-49d8-94b5-a2ce2c9efa46

positive predicate support span

Source null

qualifier mentions

context exact
• are metastatic or where surgical resection is likely to result in severe morbidity, and
kind
biomarker
polarity
not_inferred
span
end
283
end exclusive
true
exact text
metastatic or where surgical resection is l
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offset unit
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source array index
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source field
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source text sha256
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start
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context exact
• are metastatic or where surgical resection is likely to result in severe morbidity, and
kind
stage_or_setting
polarity
not_inferred
span
end
285
end exclusive
true
exact text
metastatic or where surgical resection is lik
label id
5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit
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source array index
0
source field
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source text sha256
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start
240

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 323
end exclusive: true
exact text: • are metastatic or where surgical resection is likely to result in severe morbidity, and
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 234

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b9e7961-f843-49d8-94b5-a2ce2c9efa46%22

spl effective date

2018-12-05

spl set id

9525f887-a055-4e33-8e92-898d42828cd1

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Passage 9 · unclassified context

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Passage 10 · unclassified context

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Passage 11 · approval contingency

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source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 1103

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b9e7961-f843-49d8-94b5-a2ce2c9efa46%22

spl effective date

2018-12-05

spl set id

9525f887-a055-4e33-8e92-898d42828cd1

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

Passage 12 · approval contingency

application numbers

NDA210861
NDA211710

brand names

VITRAKVI

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1360
end exclusive: true
exact text: ave no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials ( 1 , 14 ).
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 1015

current approval status

not_reconciled

duplicate text group

dup-59e61f57658b9f6a35fe

extraction review status

automated_candidate_pending_source_review

generic names

LAROTRECTINIB

ind-span-12bbc45a42376b29ea21

label id

5b9e7961-f843-49d8-94b5-a2ce2c9efa46

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1360
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials ( 1 , 14 ).
label id: 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ca1b32e8d6a6c23368e811431579059d724275b00ed1e5ea2daacb6dc18c7fa1
start: 1215

source url

https://api.fda.gov/drug/label.json?search=id%3A%225b9e7961-f843-49d8-94b5-a2ce2c9efa46%22

spl effective date

2018-12-05

spl set id

9525f887-a055-4e33-8e92-898d42828cd1

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