LABELS · 65724d4c-78ab-4d85-83b5-73b9da5c2cc3

KRAZATI

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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: 2026-03-25
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1.2 ) *These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials. ( 1.1 , 1.2 ) 1.1 KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer KRAZATI, as a single-agent, is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. 1.2 KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.

Full extracted label fields

application numbers

NDA216340

boxed warning exact

brand names

KRAZATI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b8bf078-34c2-4f45-9012-38a8ac082b01

generic names

ADAGRASIB

65724d4c-78ab-4d85-83b5-73b9da5c2cc3

indications and usage exact

1 INDICATIONS AND USAGE KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1.2 ) *These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials. ( 1.1 , 1.2 ) 1.1 KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer KRAZATI, as a single-agent, is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. 1.2 KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.

indications and usage tables exact

is original packager

true

manufacturer names

Mirati Therapeutics, Inc

matched search terms

cancer

package ndcs

80739-812-12
80739-812-18

product ndcs

80739-812

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2625917
2625923

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00400.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 · indication intro context

application numbers

NDA216340

brand names

KRAZATI

classification reasons

explicit_positive_indication_predicate
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clinical review status

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exact text: 1 INDICATIONS AND USAGE KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior syste
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current approval status

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generic names

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qualifier mentions

regulatory links

schema version

0.1.0

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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exact text
Non-small cell lung cancer (NSCLC)
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abbreviation
CRC
definition exact
Colorectal cancer
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end
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exact text
Colorectal cancer (CRC)
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exact text: 1 INDICATIONS AND USAGE KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)*
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2265724d4c-78ab-4d85-83b5-73b9da5c2cc3%22

spl effective date

2026-03-25

spl set id

0b8bf078-34c2-4f45-9012-38a8ac082b01

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 2 · positive indication candidate

application numbers

NDA216340

brand names

KRAZATI

classification reasons

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clinical review status

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exact text: 1 INDICATIONS AND USAGE KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test,
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current approval status

not_reconciled

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dup-1e00f31ae80b7acb0430

extraction review status

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generic names

ADAGRASIB

ind-span-7b03bbf36b2274bd010c

label id

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qualifier mentions

context exact
• As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC
kind
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context exact
As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have
kind
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exact text
KRAS G12C-mutated locally advanced or metast
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context exact
for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received a
kind
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exact text
locally advanced or metastatic NSCLC
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context exact
or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
kind
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exact text
who have received at least one prior systemic therapy
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context exact
• As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
kind
regimen
polarity
not_inferred
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exact text
As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at l
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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
end
122
end exclusive
true
exact text
Non-small cell lung cancer (NSCLC)
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abbreviation
CRC
definition exact
Colorectal cancer
definition span
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367
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exact text
Colorectal cancer (CRC)
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exact text: • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2265724d4c-78ab-4d85-83b5-73b9da5c2cc3%22

spl effective date

2026-03-25

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

tumor_directed_candidate

Passage 3 · unclassified context

application numbers

NDA216340

brand names

KRAZATI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

unclassified_context

context span

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exact text: e agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatmen
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current approval status

not_reconciled

duplicate text group

dup-32e266c05fda7c5db712

extraction review status

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generic names

ADAGRASIB

ind-span-c9d8dc0a459b6b875c13

label id

65724d4c-78ab-4d85-83b5-73b9da5c2cc3

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
NSCLC
definition exact
Non-small cell lung cancer
definition span
end
122
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true
exact text
Non-small cell lung cancer (NSCLC)
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abbreviation
CRC
definition exact
Colorectal cancer
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exact text
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source span

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exact text: ( 1.1 ) Colorectal cancer (CRC)*
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source url

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spl effective date

2026-03-25

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

unclear

Passage 4 · positive indication candidate

application numbers

NDA216340

brand names

KRAZATI

classification reasons

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source_defined_disease_abbreviation

clinical review status

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context span

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exact text: lt patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1.2 ) *These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent up
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qualifier mentions

context exact
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on with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have re
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context exact
for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received p
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exact text
locally advanced or metastatic CRC
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d or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
kind
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who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
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In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have recei
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Read indication-specific status → · same_indication_constraints_source_compared_NSCLC_not_included

Passage 12 · approval contingency

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exact text: cancer (CRC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.
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exact text: This indication is approved under accelerated approval based on ORR and DOR [see Clinical Studies (14.2) ] .
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Passage 13 · approval contingency

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exact text: d prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.
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source url

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Preserved source evidence · Not medical advice