LABELS · b61d5060-31ca-4067-8e5c-d31e76c6390d

PEMETREXED

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: 2024-07-24
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Pemetrexed Injection is a folate analog metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) • Limitations of Use : Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1 ) • Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed Injection is indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies 14.1 ]. 1.2 Mesothelioma Pemetrexed Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Full extracted label fields

application numbers

NDA214218

boxed warning exact

brand names

PEMETREXED

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3e087418-69ff-47fa-93c2-f28699309433

generic names

PEMETREXED

b61d5060-31ca-4067-8e5c-d31e76c6390d

indications and usage exact

1 INDICATIONS AND USAGE Pemetrexed Injection is a folate analog metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) • Limitations of Use : Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. ( 1.1 ) • Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2 ) 1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pemetrexed Injection is indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies 14.1 ]. 1.2 Mesothelioma Pemetrexed Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

indications and usage tables exact

is original packager

true

manufacturer names

Hospira, Inc.

matched search terms

cancer
malignant

package ndcs

0409-0020-02
0409-0021-03
0409-0004-04

product ndcs

0409-0004
0409-0020
0409-0021

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2602363
2602365
2602366

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 · indication intro context

application numbers

NDA214218

brand names

PEMETREXED

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

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context span

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exact text: 1 INDICATIONS AND USAGE Pemetrexed Injection is a folate analog metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) • As a single agent for the mainte
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current approval status

not_reconciled

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generic names

PEMETREXED

ind-span-d5ee0913639ecf6759c9

label id

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qualifier mentions

context exact
DICATIONS AND USAGE Pemetrexed Injection is a folate analog metabolic inhibitor indicated:
kind
biomarker
polarity
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end
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end exclusive
true
exact text
metabolic inhibitor indicated:
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regulatory links

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source defined aliases

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definition exact
non-small cell lung cancer
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exact text
non-small cell lung cancer (NSCLC)
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exact text: 1 INDICATIONS AND USAGE Pemetrexed Injection is a folate analog metabolic inhibitor indicated:
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source url

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spl effective date

2024-07-24

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 2 · positive indication candidate

application numbers

NDA214218

brand names

PEMETREXED

classification reasons

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clinical review status

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content role

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exact text: 1 INDICATIONS AND USAGE Pemetrexed Injection is a folate analog metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based fir
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current approval status

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extraction review status

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generic names

PEMETREXED

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label id

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positive predicate support span

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exact text: is a folate analog metabolic inhibitor indicated
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qualifier mentions

context exact
the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
kind
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exact text
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context exact
n with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
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exact text
locally advanced or metastatic
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context exact
• In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
kind
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end
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exact text
In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC)
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source defined aliases

abbreviation
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definition exact
non-small cell lung cancer
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exact text
non-small cell lung cancer (NSCLC)
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exact text: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
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start: 95

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b61d5060-31ca-4067-8e5c-d31e76c6390d%22

spl effective date

2024-07-24

spl set id

3e087418-69ff-47fa-93c2-f28699309433

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 3 · unclassified context

application numbers

NDA214218

brand names

PEMETREXED

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

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end exclusive: true
exact text: late analog metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line
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current approval status

not_reconciled

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extraction review status

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generic names

PEMETREXED

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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
non-small cell lung cancer
definition span
end
250
end exclusive
true
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

https://api.fda.gov/drug/label.json?search=id%3A%22b61d5060-31ca-4067-8e5c-d31e76c6390d%22

spl effective date

2024-07-24

spl set id

3e087418-69ff-47fa-93c2-f28699309433

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

unclear

Passage 4 · positive indication candidate

application numbers

NDA214218

brand names

PEMETREXED

classification reasons

inherited_predicate_from_same_label_section_requires_review
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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end exclusive: true
exact text: log metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) • Limitations of Use : Pemetrexed Injection is not indicated
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current approval status

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generic names

PEMETREXED

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label id

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positive predicate support span

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exact text: is a folate analog metabolic inhibitor indicated
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qualifier mentions

context exact
maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after
kind
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ease has not progressed after four cycles of platinum-based first-line chemotherapy.
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• As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
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As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platin
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regulatory links

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source defined aliases

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exact text: • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
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source url

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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

tumor_directed_candidate

Passage 5 · unclassified context

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: agent for the maintenance treatment of patients with locally advanced or metastatic, non -squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. ( 1.1 ) • Limitations of Use : Pemetrexed Injection is not indicated for the
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schema version

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source defined aliases

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source text sha256: 04e92e224776555187813cdd78c1a7a4baf28159189ed7232e558168e881ac9f
start: 1737

qualifier mentions

context exact
tients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
kind
stage_or_setting
polarity
not_inferred
span
end
1920
end exclusive
true
exact text
unresectable or who are otherwise not candidate
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start
1873
context exact
1.2 Mesothelioma Pemetrexed Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
kind
regimen
polarity
not_inferred
span
end
1930
end exclusive
true
exact text
in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for cura
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start
1751

regulatory links

schema version

0.1.0

source batch sha256

a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
250
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source field
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start
216

source span

end: 1943
end exclusive: true
exact text: 1.2 Mesothelioma Pemetrexed Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
label id: b61d5060-31ca-4067-8e5c-d31e76c6390d
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 04e92e224776555187813cdd78c1a7a4baf28159189ed7232e558168e881ac9f
start: 1699

source url

https://api.fda.gov/drug/label.json?search=id%3A%22b61d5060-31ca-4067-8e5c-d31e76c6390d%22

spl effective date

2024-07-24

spl set id

3e087418-69ff-47fa-93c2-f28699309433

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

non_oncology_or_unclear_candidate

Preserved source evidence · Not medical advice