LABELS · 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c

Gavreto

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: 2025-12-05
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 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 trial(s). ( 1.2 ) 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 1.2 RET Fusion-Positive Thyroid Cancer GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Full extracted label fields

application numbers

NDA213721

boxed warning exact

brand names

Gavreto

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=59984249-e3ff-4f97-8d7a-c1a905d604a8

generic names

PRALSETINIB

202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c

indications and usage exact

1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 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 trial(s). ( 1.2 ) 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 1.2 RET Fusion-Positive Thyroid Cancer GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

indications and usage tables exact

is original packager

true

manufacturer names

Genentech, Inc.

matched search terms

cancer

package ndcs

50242-210-90
50242-210-60
50242-210-83
50242-210-12

product ndcs

50242-210

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage, Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer – Accelerated Approval text removed (1.1) (8/2023) Indications and Usage, RET -Mutant Medullary Thyroid Cancer –Indication Removed (1.2) (7/2023) Dosage and Administration ( 2.1 ) (7/2023) Dosage and Administration, Dose Modification for Use with CYP3A and/or P-glycoprotein (P-gp) Inhibitors ( 2.4 ) (6/2023) Dosage and Administration, Dose Modification for Use with CYP3A Inducers ( 2.5 ) (6/2023)

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2394941
2394947

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.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

NDA213721

brand names

Gavreto

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: 438
end exclusive: true
exact text: 1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (i
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current approval status

not_reconciled

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extraction review status

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generic names

PRALSETINIB

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label id

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positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
E GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusio
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exact text
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context exact
e inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected
kind
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polarity
not_inferred
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end
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end exclusive
true
exact text
metastatic rearranged during transfection (
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context exact
lt patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
kind
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polarity
not_inferred
span
end
188
end exclusive
true
exact text
RET ) fusion-positive non-small cell lung c
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context exact
e inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected b
kind
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exact text
metastatic rearranged during transfection (RE
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regulatory links

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source defined aliases

abbreviation
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definition exact
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exact text
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exact text: 1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
label id: 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
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start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c%22

spl effective date

2025-12-05

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

NDA213721

brand names

Gavreto

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 446
end exclusive: true
exact text: nase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioa
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current approval status

not_reconciled

duplicate text group

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extraction review status

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generic names

PRALSETINIB

ind-span-9cc05705a56f23d5d5e7

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

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

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end exclusive: true
exact text: ( 1.1 )
label id: 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
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start: 239

source url

https://api.fda.gov/drug/label.json?search=id%3A%22202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c%22

spl effective date

2025-12-05

spl set id

59984249-e3ff-4f97-8d7a-c1a905d604a8

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

NDA213721

brand names

Gavreto

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: 675
end exclusive: true
exact text: ibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 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 descript
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current approval status

not_reconciled

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extraction review status

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generic names

PRALSETINIB

ind-span-009f5b42d38fc7e78f85

label id

202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c

positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
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source text sha256: a136bc103db4e1681d77160b9ab5e4b852f4718c14a33403471c1713c3af3e9d
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qualifier mentions

context exact
Adult and pediatric patients 12 years of age and older with advan
kind
age
polarity
not_inferred
span
end
252
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true
exact text
Adult
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context exact
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET f
kind
age
polarity
not_inferred
span
end
275
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true
exact text
pediatric patients
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context exact
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive t
kind
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true
exact text
12 years of age
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context exact
diatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodi
kind
biomarker
polarity
not_inferred
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exact text
metastatic RET fusion-positive thyroid canc
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context exact
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exact text
advanced or metastatic RET fusion-positive
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context exact
who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
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exact text
refractory (if radioactive iodine is appropri
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regulatory links

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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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exact text
non-small cell lung cancer (NSCLC)
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exact text: Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c%22

spl effective date

2025-12-05

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 4 · approval contingency

application numbers

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brand names

Gavreto

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clinical review status

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exact text: 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 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 trial(s). ( 1.2 ) 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung
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current approval status

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label id

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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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definition span
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exact text
non-small cell lung cancer (NSCLC)
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exact text: This indication is approved under accelerated approval based on overall response rate and duration of response.
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start: 476

source url

https://api.fda.gov/drug/label.json?search=id%3A%22202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c%22

spl effective date

2025-12-05

spl set id

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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 5 · approval contingency

application numbers

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brand names

Gavreto

classification reasons

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clinical review status

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exact text: erapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 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 trial(s). ( 1.2 ) 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) a
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current approval status

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qualifier mentions

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schema version

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888

source span

end: 1413
end exclusive: true
exact text: This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] .
label id: 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
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source field: indications_and_usage_exact
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c%22

spl effective date

2025-12-05

spl set id

59984249-e3ff-4f97-8d7a-c1a905d604a8

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 10 · approval contingency

application numbers

NDA213721

brand names

Gavreto

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1550
end exclusive: true
exact text: dine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
label id: 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
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current approval status

not_reconciled

duplicate text group

dup-f101416df8fa850207b7

extraction review status

automated_candidate_pending_source_review

generic names

PRALSETINIB

ind-span-09be16ac5b28f0292b36

label id

202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
922
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
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unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
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start
888

source span

end: 1550
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
label id: 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: a136bc103db4e1681d77160b9ab5e4b852f4718c14a33403471c1713c3af3e9d
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c%22

spl effective date

2025-12-05

spl set id

59984249-e3ff-4f97-8d7a-c1a905d604a8

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