LABELS · 8f611e67-8c58-4413-8b81-a200fa7f30e8

LUMAKRAS

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: 2025-01-22
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic 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 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. ( 1.2 ) 1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS 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 overall 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 clinical benefit in a confirmatory trial(s). 1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.2) ] .

Full extracted label fields

application numbers

NDA214665

boxed warning exact

brand names

LUMAKRAS

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c80a362c-7ac3-4894-a076-0691e68ef8c1

generic names

SOTORASIB

8f611e67-8c58-4413-8b81-a200fa7f30e8

indications and usage exact

1 INDICATIONS AND USAGE LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic 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 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. ( 1.2 ) 1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS 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 overall 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 clinical benefit in a confirmatory trial(s). 1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.2) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Amgen Inc

matched search terms

cancer

package ndcs

55513-488-01
55513-488-02
55513-488-40
55513-488-24
55513-488-96
55513-504-50
55513-512-60

product ndcs

55513-488
55513-504
55513-512

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1 ) 01/2025 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 01/2025 Warnings and Precaution ( 5.1 , 5.2 ) 01/2025

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2550719
2550725
2628240
2628242
2687205
2687207

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00500.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

NDA214665

brand names

LUMAKRAS

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: 582
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic 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 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verif
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 0

current approval status

not_reconciled

duplicate text group

dup-fa92c1e2408fa2cafe98

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-681a0316ad1d915f568f

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

end: 83
end exclusive: true
exact text: is an inhibitor of the RAS GTPase family indicated
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 33

qualifier mentions

context exact
Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC
kind
age
polarity
not_inferred
span
end
227
end exclusive
true
exact text
adult patients
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
213
context exact
RAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, f
kind
biomarker
polarity
not_inferred
span
end
133
end exclusive
true
exact text
KRAS G12C-mutated Locally Advanced or Metast
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
89
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
biomarker
polarity
not_inferred
span
end
277
end exclusive
true
exact text
KRAS G12C-mutated locally advanced or metast
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
233
context exact
r of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult
kind
stage_or_setting
polarity
not_inferred
span
end
158
end exclusive
true
exact text
Locally Advanced or Metastatic Non-Small Cell Lung
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
107
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
stage_or_setting
polarity
not_inferred
span
end
287
end exclusive
true
exact text
locally advanced or metastatic NSCLC
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
251
context exact
or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
381
end exclusive
true
exact text
who have received at least one prior systemic therapy
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
328
context exact
y Advanced or Metastatic 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.
kind
regimen
polarity
not_inferred
span
end
350
end exclusive
true
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
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
173

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 382
end exclusive: true
exact text: 1 INDICATIONS AND USAGE LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic 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.
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 · approval contingency

application numbers

NDA214665

brand names

LUMAKRAS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 714
end exclusive: true
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 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 183

current approval status

not_reconciled

duplicate text group

dup-43012a73e813fb3685b0

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-a6206bf5e9264639be46

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 514
end exclusive: true
exact text: ( 1.1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR).
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 383

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 3 · approval contingency

application numbers

NDA214665

brand names

LUMAKRAS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 853
end exclusive: true
exact text: proved test, who have received at least one prior systemic therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, w
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 315

current approval status

not_reconciled

duplicate text group

dup-3b8908f877d8adc532cd

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-05c22b71049fe8e501ec

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 653
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 515

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 4 · unclassified context

application numbers

NDA214665

brand names

LUMAKRAS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1142
end exclusive: true
exact text: overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. ( 1.2 ) 1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS as a single agent is indicated for the treatment of adult patients with KRAS G12C -mutated loc
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 454

current approval status

not_reconciled

duplicate text group

dup-32420d3b1b5526510a76

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-bdc6df942edbed4dd6b7

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

Source null

qualifier mentions

context exact
mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approve
kind
age
polarity
not_inferred
span
end
784
end exclusive
true
exact text
adult patients
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
770
context exact
( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment
kind
biomarker
polarity
not_inferred
span
end
706
end exclusive
true
exact text
KRAS G12C-mutated Metastatic Colorectal Canc
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
662
context exact
with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-,
kind
biomarker
polarity
not_inferred
span
end
834
end exclusive
true
exact text
KRAS G12C-mutated mCRC as determined by an F
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
790
context exact
( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients
kind
stage_or_setting
polarity
not_inferred
span
end
725
end exclusive
true
exact text
Metastatic Colorectal Cancer (mCRC) In combin
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
680
context exact
AS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
941
end exclusive
true
exact text
who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
852
context exact
1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
kind
regimen
polarity
not_inferred
span
end
895
end exclusive
true
exact text
In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-,
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
716

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 942
end exclusive: true
exact text: ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 654

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 5 · unclassified context

application numbers

NDA214665

brand names

LUMAKRAS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1150
end exclusive: true
exact text: umab, for the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. ( 1.2 ) 1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS as a single agent is indicated for the treatment of adult patients with KRAS G12C -mutated locally adv
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 743

current approval status

not_reconciled

duplicate text group

dup-2149b2b5203bfc5f17fd

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-7d3a01572f654652bfb6

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 950
end exclusive: true
exact text: ( 1.2 )
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 943

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 6 · positive indication candidate

application numbers

NDA214665

brand names

LUMAKRAS

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: 1539
end exclusive: true
exact text: r the treatment of adult patients with KRAS G12C-mutated mCRC as determined by an FDA approved-test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. ( 1.2 ) 1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS 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 overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14.1) ] . Continued approval for this indication may
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 751

current approval status

not_reconciled

duplicate text group

dup-8e07d7487d87205b9460

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-e9d3a851017ce4160159

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

end: 1078
end exclusive: true
exact text: is indicated
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1066

qualifier mentions

context exact
UMAKRAS as a single agent is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic non-
kind
age
polarity
not_inferred
span
end
1114
end exclusive
true
exact text
adult patients
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1100
context exact
1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS as a single
kind
biomarker
polarity
not_inferred
span
end
999
end exclusive
true
exact text
KRAS G12C-mutated Locally Advanced or Metast
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
955
context exact
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 a
kind
biomarker
polarity
not_inferred
span
end
1164
end exclusive
true
exact text
KRAS G12C -mutated locally advanced or metas
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1120
context exact
1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS as a single agent is indicated for t
kind
stage_or_setting
polarity
not_inferred
span
end
1024
end exclusive
true
exact text
Locally Advanced or Metastatic Non-Small Cell Lung
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
973
context exact
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 D
kind
stage_or_setting
polarity
not_inferred
span
end
1190
end exclusive
true
exact text
locally advanced or metastatic non-small cell lung
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1139
context exact
FDA-approved test [see Dosage and Administration (2.1) ] , who have received at least one prior systemic therapy.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1338
end exclusive
true
exact text
who have received at least one prior systemic therapy
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1285
context exact
d or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS 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) ] ,
kind
regimen
polarity
not_inferred
span
end
1225
end exclusive
true
exact text
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
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1048

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 1339
end exclusive: true
exact text: 1.1 KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) LUMAKRAS 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.
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 951

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 7 · approval contingency

application numbers

NDA214665

brand names

LUMAKRAS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1695
end exclusive: true
exact text: ocally 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 overall 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 clinical benefit in a confirmatory trial(s). 1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LU
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1140

current approval status

not_reconciled

duplicate text group

dup-a459cee7d823cb0ea608

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-2f135d0fb86352bb2f38

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 1495
end exclusive: true
exact text: This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies (14.1) ] .
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1340

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 8 · approval contingency

application numbers

NDA214665

brand names

LUMAKRAS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1834
end exclusive: true
exact text: ceived at least one prior systemic therapy. This indication is approved under accelerated approval based on overall 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 clinical benefit in a confirmatory trial(s). 1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal can
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1296

current approval status

not_reconciled

duplicate text group

dup-3b8908f877d8adc532cd

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-348901d9e175aabab744

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 1634
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1496

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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 9 · positive indication candidate

application numbers

NDA214665

brand names

LUMAKRAS

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: 2043
end exclusive: true
exact text: duration of response (DOR) [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.2) ] .
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1435

current approval status

not_reconciled

duplicate text group

dup-0ab9320ed1119fe67fe6

extraction review status

automated_candidate_pending_source_review

generic names

SOTORASIB

ind-span-9c668c3d567ae08e70d3

label id

8f611e67-8c58-4413-8b81-a200fa7f30e8

positive predicate support span

end: 1748
end exclusive: true
exact text: is indicated
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1736

qualifier mentions

context exact
ination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC)
kind
age
polarity
not_inferred
span
end
1784
end exclusive
true
exact text
adult patients
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1770
context exact
1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indi
kind
biomarker
polarity
not_inferred
span
end
1683
end exclusive
true
exact text
KRAS G12C-mutated Metastatic Colorectal Canc
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1639
context exact
umab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have
kind
biomarker
polarity
not_inferred
span
end
1834
end exclusive
true
exact text
KRAS G12C -mutated metastatic colorectal can
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1790
context exact
1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the trea
kind
stage_or_setting
polarity
not_inferred
span
end
1701
end exclusive
true
exact text
Metastatic Colorectal Cancer (mCRC) LUMAKRAS
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1657
context exact
for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received p
kind
stage_or_setting
polarity
not_inferred
span
end
1844
end exclusive
true
exact text
metastatic colorectal cancer (mCRC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1809
context exact
ectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.2) ] .
kind
prior_therapy_or_line
polarity
not_inferred
span
end
2008
end exclusive
true
exact text
who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy [see Dosage and Administration (2
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1885
context exact
G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- a
kind
regimen
polarity
not_inferred
span
end
1882
end exclusive
true
exact text
in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved tes
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
1703

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
Non-Small Cell Lung Cancer
definition span
end
172
end exclusive
true
exact text
Non-Small Cell Lung Cancer (NSCLC)
label id
8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start
138

source span

end: 2043
end exclusive: true
exact text: 1.2 KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C -mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.2) ] .
label id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: ff6cb1d74495fac6737033eacb838ecb08ad52f2ec7a820b1b2d72c920a13923
start: 1635

source url

https://api.fda.gov/drug/label.json?search=id%3A%228f611e67-8c58-4413-8b81-a200fa7f30e8%22

spl effective date

2025-01-22

spl set id

c80a362c-7ac3-4894-a076-0691e68ef8c1

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

Preserved source evidence · Not medical advice