LABELS · b93e1fc0-614a-4e49-a91d-a409fb2db9f0

Rozlytrek

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: 2025-12-04
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer ROZLYTREK is indicated for the treatment of adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. 1.2 NTRK Gene Fusion-Positive Solid Tumors ROZLYTREK is indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Full extracted label fields

application numbers

NDA212725
NDA218550

boxed warning exact

brand names

Rozlytrek

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7c71b0c-2549-4495-86b6-c2807fa54908

generic names

ENTRECTINIB

b93e1fc0-614a-4e49-a91d-a409fb2db9f0

indications and usage exact

1 INDICATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer ROZLYTREK is indicated for the treatment of adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. 1.2 NTRK Gene Fusion-Positive Solid Tumors ROZLYTREK is indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

indications and usage tables exact

is original packager

true

manufacturer names

Genentech, Inc.

matched search terms

cancer
tumor
tumors

package ndcs

50242-091-30
50242-091-86
50242-094-47
50242-094-90
50242-623-01
50242-623-42

product ndcs

50242-091
50242-094
50242-623

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.2 ) 10/2023 Dosage and Administration ( 2.1 , 2.3 , 2.4 , 2.6 , 2.7 , 2.8 , 2.9 ) 10/2023 Dosage and Administration ( 2.2 ) 01/2024 Warnings and Precautions ( 5.1 ) 01/2024 Warnings and Precautions ( 5.3 ) 10/2023

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2197867
2197873
2197875
2197877
2668595
2668599

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.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 · positive indication candidate

application numbers

NDA212725
NDA218550

brand names

Rozlytrek

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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context span

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exact text: 1 INDICATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a
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current approval status

not_reconciled

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generic names

ENTRECTINIB

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exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
YTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (
kind
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end
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context exact
hibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
kind
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not_inferred
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end
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end exclusive
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exact text
ROS1- positive metastatic non-small cell lun
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context exact
ed for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
kind
stage_or_setting
polarity
not_inferred
span
end
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exact text
metastatic non-small cell lung cancer (NSCLC)
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regulatory links

schema version

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source batch sha256

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source defined aliases

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definition exact
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definition span
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exact text
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exact text: 1 INDICATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b93e1fc0-614a-4e49-a91d-a409fb2db9f0%22

spl effective date

2025-12-04

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

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

NDA212725
NDA218550

brand names

Rozlytrek

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

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context span

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end exclusive: true
exact text: CATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known ac
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current approval status

not_reconciled

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extraction review status

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generic names

ENTRECTINIB

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label id

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positive predicate support span

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qualifier mentions

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schema version

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source batch sha256

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source defined aliases

abbreviation
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definition exact
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definition span
end
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exact text
non-small cell lung cancer (NSCLC)
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source span

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exact text: ( 1.1 )
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source url

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spl effective date

2025-12-04

spl set id

c7c71b0c-2549-4495-86b6-c2807fa54908

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 · positive indication candidate

application numbers

NDA212725
NDA218550

brand names

Rozlytrek

classification reasons

inherited_predicate_from_same_label_section_requires_review
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

pending

content role

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context span

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exact text: AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and descript
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current approval status

not_reconciled

duplicate text group

dup-30d14fe97c8aa8df9898

extraction review status

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generic names

ENTRECTINIB

ind-span-5164ffd18427159bb6eb

label id

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positive predicate support span

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exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
Adult and pediatric patients older than 1 month of age with solid
kind
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polarity
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exact text
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context exact
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polarity
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span
end
242
end exclusive
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exact text
pediatric patients
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source text sha256
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context exact
tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquir
kind
biomarker
polarity
not_inferred
span
end
357
end exclusive
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exact text
NTRK) gene fusion
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context exact
oved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed fol
kind
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polarity
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span
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488
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exact text
metastatic or where surgical resection is l
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context exact
oved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed follo
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polarity
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exact text
metastatic or where surgical resection is lik
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morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
kind
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polarity
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exact text
no satisfactory alternative therapy
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regulatory links

schema version

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source batch sha256

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source defined aliases

abbreviation
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definition exact
non-small cell lung cancer
definition span
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end exclusive
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exact text
non-small cell lung cancer (NSCLC)
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exact text: Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22b93e1fc0-614a-4e49-a91d-a409fb2db9f0%22

spl effective date

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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
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 4 · approval contingency

application numbers

NDA212725
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brand names

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classification reasons

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clinical review status

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exact text: acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer ROZLYT
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current approval status

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source defined aliases

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definition exact
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exact text
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source span

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exact text: This indication is approved under accelerated approval based on tumor response rate and durability of response.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22b93e1fc0-614a-4e49-a91d-a409fb2db9f0%22

spl effective date

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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 5 · approval contingency

application numbers

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brand names

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classification reasons

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clinical review status

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exact text: y, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ( 1.2 ) 1.1 ROS1 -Positive Non-Small Cell Lung Cancer ROZLYTREK is indicated for the treatment of adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC), as detected by an F
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current approval status

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source text sha256: 3ae22b3f795489b62ce28ea64a06d229f5a780fec8f995a28fff38e90e8a774c
start: 1704

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b93e1fc0-614a-4e49-a91d-a409fb2db9f0%22

spl effective date

2025-12-04

spl set id

c7c71b0c-2549-4495-86b6-c2807fa54908

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