LABELS · 49baf2a0-c1bf-49a8-a2f9-176cae0b7410

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: 2026-06-18
Captured: 2026-09-09T23:37:44.904352+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=caef07ce-066b-4c48-98dc-974b05ebbbe0

generic names

PEMETREXED

49baf2a0-c1bf-49a8-a2f9-176cae0b7410

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

Acacia Pharma, Ltd.

matched search terms

cancer
tumor
malignant

package ndcs

71390-250-02

product ndcs

71390-250

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-00200.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

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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
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current approval status

not_reconciled

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generic names

PEMETREXED

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exact text: is a folate analog metabolic inhibitor indicated
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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
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exact text
metabolic inhibitor indicated for: in combi
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um chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
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exact text
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context exact
ent of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
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exact text
EGFR or ALK genomic tumor aberrations
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context exact
um chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
kind
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exact text
metastatic non-squamous NSCLC
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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
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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
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regulatory links

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source defined aliases

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definition exact
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exact text
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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.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2249baf2a0-c1bf-49a8-a2f9-176cae0b7410%22

spl effective date

2026-06-18

spl set id

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spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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

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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
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current approval status

not_reconciled

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generic names

PEMETREXED

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source batch sha256

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source defined aliases

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definition exact
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exact text
non-small cell lung cancer (NSCLC)
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exact text: ( 1.1 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2249baf2a0-c1bf-49a8-a2f9-176cae0b7410%22

spl effective date

2026-06-18

spl set id

caef07ce-066b-4c48-98dc-974b05ebbbe0

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 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

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context span

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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
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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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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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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
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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regulatory links

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source defined aliases

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

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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 url

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spl effective date

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spl set id

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approval pathway: Source null
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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

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brand names

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classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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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
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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

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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 5 · positive indication candidate

application numbers

NDA209472

brand names

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classification reasons

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tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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

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Preserved source evidence · Not medical advice