LABELS · efadeccf-c754-46aa-999e-4da07a4cd2ce

Pemfexy

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: 2026-02-20
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) 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. ( 1.2 ) 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ]. 1.2 Mesothelioma PEMFEXY 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

NDA209472

boxed warning exact

brand names

Pemfexy

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2308f4e8-21c8-49c1-a5b8-deb8610bac6a

generic names

PEMETREXED

efadeccf-c754-46aa-999e-4da07a4cd2ce

indications and usage exact

1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) 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. ( 1.2 ) 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ]. 1.2 Mesothelioma PEMFEXY 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

Eagle Pharmaceuticals, Inc.

matched search terms

cancer
tumor
malignant

package ndcs

42367-531-33

product ndcs

42367-531

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2590672
2590677

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00700.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

NDA209472

brand names

Pemfexy

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: 468
end exclusive: true
exact text: 1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) 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 mai
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 0

current approval status

not_reconciled

duplicate text group

dup-a1c2615a1a76a2a2250e

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-9beb547cad7ee2b41c78

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

end: 81
end exclusive: true
exact text: is a folate analog metabolic inhibitor indicated
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 33

qualifier mentions

context exact
1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the
kind
biomarker
polarity
not_inferred
span
end
95
end exclusive
true
exact text
metabolic inhibitor indicated for: in combi
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
52
context exact
um chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
kind
biomarker
polarity
not_inferred
span
end
220
end exclusive
true
exact text
metastatic non-squamous NSCLC
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
191
context exact
ent of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
kind
biomarker
polarity
not_inferred
span
end
267
end exclusive
true
exact text
EGFR or ALK genomic tumor aberrations
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
230
context exact
um chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
kind
stage_or_setting
polarity
not_inferred
span
end
220
end exclusive
true
exact text
metastatic non-squamous NSCLC
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
191
context exact
FEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
kind
regimen
polarity
not_inferred
span
end
266
end exclusive
true
exact text
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberration
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
87

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 268
end exclusive: true
exact text: 1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 · unclassified context

application numbers

NDA209472

brand names

Pemfexy

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 476
end exclusive: true
exact text: or indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) 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
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 69

current approval status

not_reconciled

duplicate text group

dup-3a581328c7b1fc743b99

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-ef4384a263166fcc4b40

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 276
end exclusive: true
exact text: ( 1.1 )
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 269

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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

NDA209472

brand names

Pemfexy

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: 630
end exclusive: true
exact text: ated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) 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-l
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 77

current approval status

not_reconciled

duplicate text group

dup-9458087cb938d4efdd34

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-719da2e55a997e8a30c9

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

end: 81
end exclusive: true
exact text: is a folate analog metabolic inhibitor indicated
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 33

qualifier mentions

context exact
the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC).
kind
biomarker
polarity
not_inferred
span
end
393
end exclusive
true
exact text
metastatic non-squamous
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
370
context exact
n with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC).
kind
stage_or_setting
polarity
not_inferred
span
end
393
end exclusive
true
exact text
locally advanced or metastatic non-squamous
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
350
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
regimen
polarity
not_inferred
span
end
429
end exclusive
true
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)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
277

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 430
end exclusive: true
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).
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 277

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 4 · unclassified context

application numbers

NDA209472

brand names

Pemfexy

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 638
end exclusive: true
exact text: GFR or ALK genomic tumor aberrations. ( 1.1 ) 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 chem
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 231

current approval status

not_reconciled

duplicate text group

dup-3a581328c7b1fc743b99

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-8ef741d4b329315832f4

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 438
end exclusive: true
exact text: ( 1.1 )
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 431

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 · positive indication candidate

application numbers

NDA209472

brand names

Pemfexy

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: 847
end exclusive: true
exact text: LK genomic tumor aberrations. ( 1.1 ) 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 : PEMFEXY is not indicated for the treatment
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 239

current approval status

not_reconciled

duplicate text group

dup-5782b751429da1bc55b6

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-b2cac4bd6b92ebf9ab67

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

end: 81
end exclusive: true
exact text: is a folate analog metabolic inhibitor indicated
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 33

qualifier mentions

context exact
maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based firs
kind
biomarker
polarity
not_inferred
span
end
567
end exclusive
true
exact text
metastatic non-squamous NSCLC whose disease
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
524
context exact
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 platinu
kind
stage_or_setting
polarity
not_inferred
span
end
555
end exclusive
true
exact text
locally advanced or metastatic non-squamous NSCLC w
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
504
context exact
ease has not progressed after four cycles of platinum-based first-line chemotherapy.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
646
end exclusive
true
exact text
first-line chemotherapy
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
623
context exact
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.
kind
regimen
polarity
not_inferred
span
end
616
end exclusive
true
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
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
439

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 647
end exclusive: true
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.
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 439

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 6 · unclassified context

application numbers

NDA209472

brand names

Pemfexy

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 855
end exclusive: true
exact text: le 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 : PEMFEXY is not indicated for the treatment of pati
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 448

current approval status

not_reconciled

duplicate text group

dup-3a581328c7b1fc743b99

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-f775ebc166da0cfdba0d

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 655
end exclusive: true
exact text: ( 1.1 )
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 648

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 7 · positive indication candidate

application numbers

NDA209472

brand names

Pemfexy

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: 975
end exclusive: true
exact text: 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) in combination with cisplatin for the initial treatment, of
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 456

current approval status

not_reconciled

duplicate text group

dup-242a8cdd3c3e0d5214ce

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-d74033a3823fa43c442a

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

end: 81
end exclusive: true
exact text: is a folate analog metabolic inhibitor indicated
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 33

qualifier mentions

context exact
single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
biomarker
polarity
not_inferred
span
end
763
end exclusive
true
exact text
metastatic non-squamous NSCLC after prior c
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
720
context exact
as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
stage_or_setting
polarity
not_inferred
span
end
718
end exclusive
true
exact text
recurrent
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
709
context exact
single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
stage_or_setting
polarity
not_inferred
span
end
765
end exclusive
true
exact text
metastatic non-squamous NSCLC after prior che
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
720
context exact
as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
regimen
polarity
not_inferred
span
end
774
end exclusive
true
exact text
as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
656

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 775
end exclusive: true
exact text: as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 656

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 8 · limitation of use

application numbers

NDA209472

brand names

Pemfexy

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 1106
end exclusive: true
exact text: 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) 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: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 576

current approval status

not_reconciled

duplicate text group

dup-3647114430e34208f675

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-724e5dfe9b5781dc61cf

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 906
end exclusive: true
exact text: ( 1.1 ) Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer.
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 776

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 · unclassified context

application numbers

NDA209472

brand names

Pemfexy

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1114
end exclusive: true
exact text: h recurrent, metastatic non-squamous NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) 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. ( 1.2
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 707

current approval status

not_reconciled

duplicate text group

dup-3a581328c7b1fc743b99

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-ebe541b03dae1ba1737d

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 914
end exclusive: true
exact text: ( 1.1 )
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 907

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 10 · unclassified context

application numbers

NDA209472

brand names

Pemfexy

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1307
end exclusive: true
exact text: ent, metastatic non-squamous NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) 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. ( 1.2 ) 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squa
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 715

current approval status

not_reconciled

duplicate text group

dup-b135632cb6c9260e653f

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-982950819869a54fba44

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

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
1084
end exclusive
true
exact text
unresectable or who are otherwise not candidate
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1037
context exact
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
1094
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
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
915

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 1107
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 curative surgery.
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 915

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 11 · unclassified context

application numbers

NDA209472

brand names

Pemfexy

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1315
end exclusive: true
exact text: 1.1 ) 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. ( 1.2 ) 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 908

current approval status

not_reconciled

duplicate text group

dup-e0205dd346cb684855b3

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-7ab15345fdea79eedad3

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 1115
end exclusive: true
exact text: ( 1.2 )
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1108

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 12 · positive indication candidate

application numbers

NDA209472

brand names

Pemfexy

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: 2048
end exclusive: true
exact text: n 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. ( 1.2 ) 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ]. 1.2 Mesothelioma PEMFEXY is indicated in combination with cisplatin
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 916

current approval status

not_reconciled

duplicate text group

dup-a71befb679b042ddb50e

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-95bd9cf25d99b12e80f9

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

end: 1182
end exclusive: true
exact text: is indicated
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1170

qualifier mentions

context exact
um chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberratio
kind
biomarker
polarity
not_inferred
span
end
1331
end exclusive
true
exact text
metastatic non-squamous non-small cell lung
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1288
context exact
ic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplatin for the initial treatment of
kind
biomarker
polarity
not_inferred
span
end
1393
end exclusive
true
exact text
EGFR or ALK genomic tumor aberrations
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1356
context exact
the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. as a single agent for the maintenance
kind
biomarker
polarity
not_inferred
span
end
1498
end exclusive
true
exact text
metastatic
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1488
context exact
maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based firs
kind
biomarker
polarity
not_inferred
span
end
1648
end exclusive
true
exact text
metastatic non-squamous NSCLC whose disease
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1605
context exact
single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
biomarker
polarity
not_inferred
span
end
1836
end exclusive
true
exact text
metastatic non-squamous NSCLC after prior c
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1793
context exact
um chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations
kind
stage_or_setting
polarity
not_inferred
span
end
1333
end exclusive
true
exact text
metastatic non-squamous non-small cell lung c
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1288
context exact
n with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. as a single agent for the maintenance
kind
stage_or_setting
polarity
not_inferred
span
end
1498
end exclusive
true
exact text
locally advanced or metastatic
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1468
context exact
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 platinu
kind
stage_or_setting
polarity
not_inferred
span
end
1636
end exclusive
true
exact text
locally advanced or metastatic non-squamous NSCLC w
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1585
context exact
erapy. as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1791
end exclusive
true
exact text
recurrent
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1782
context exact
single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1838
end exclusive
true
exact text
metastatic non-squamous NSCLC after prior che
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1793
context exact
ease has not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recur
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1727
end exclusive
true
exact text
first-line chemotherapy
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1704
context exact
squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplati
kind
regimen
polarity
not_inferred
span
end
1363
end exclusive
true
exact text
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
1184

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 1848
end exclusive: true
exact text: 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous 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.
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1116

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 13 · limitation of use

application numbers

NDA209472

brand names

Pemfexy

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 2179
end exclusive: true
exact text: 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 : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ]. 1.2 Mesothelioma PEMFEXY 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 ca
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1649

current approval status

not_reconciled

duplicate text group

dup-da95c3696c5e699615aa

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-6274eb98650d3d63250a

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 1979
end exclusive: true
exact text: Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ].
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1849

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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 14 · positive indication candidate

application numbers

NDA209472

brand names

Pemfexy

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2209
end exclusive: true
exact text: h recurrent, metastatic non-squamous NSCLC after prior chemotherapy. Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ]. 1.2 Mesothelioma PEMFEXY 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: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1780

current approval status

not_reconciled

duplicate text group

dup-a579a5430b45a0b73e0e

extraction review status

automated_candidate_pending_source_review

generic names

PEMETREXED

ind-span-4be17fabcbaaa1817ed2

label id

efadeccf-c754-46aa-999e-4da07a4cd2ce

positive predicate support span

end: 2017
end exclusive: true
exact text: is indicated
label id: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 2005

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
2186
end exclusive
true
exact text
unresectable or who are otherwise not candidate
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
2139
context exact
1.2 Mesothelioma PEMFEXY 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
2197
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 curat
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
2018

regulatory links

schema version

0.1.0

source batch sha256

24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
429
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start
395

source span

end: 2209
end exclusive: true
exact text: 1.2 Mesothelioma PEMFEXY 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: efadeccf-c754-46aa-999e-4da07a4cd2ce
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 275bc851b38915b650efb7a324fefad1eb899187e4633dfe7d7ffdc03178c5cb
start: 1980

source url

https://api.fda.gov/drug/label.json?search=id%3A%22efadeccf-c754-46aa-999e-4da07a4cd2ce%22

spl effective date

2026-02-20

spl set id

2308f4e8-21c8-49c1-a5b8-deb8610bac6a

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