LABELS · 91ad9008-46bd-4619-946f-75174fceaf56

ZYNYZ

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-05-18
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). ( 1.2 ) 1.1 Squamous Cell Carcinoma of the Anal Canal ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ZYNYZ, as a single agent, is indicated for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum‑based chemotherapy. 1.2 Merkel Cell Carcinoma ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

Full extracted label fields

application numbers

BLA761334

boxed warning exact

brand names

ZYNYZ

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=109648d0-d30a-42fc-8273-39cb1540a751

generic names

RETIFANLIMAB-DLWR

91ad9008-46bd-4619-946f-75174fceaf56

indications and usage exact

1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). ( 1.2 ) 1.1 Squamous Cell Carcinoma of the Anal Canal ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ZYNYZ, as a single agent, is indicated for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum‑based chemotherapy. 1.2 Merkel Cell Carcinoma ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

indications and usage tables exact

is original packager

true

manufacturer names

Incyte Corporation

matched search terms

carcinoma

package ndcs

50881-006-03

product ndcs

50881-006

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.1 ) 5/2025 Indications and Usage ( 1.2 ) 12/2025 Dosage and Administration ( 2.1 , 2.3 ) 3/2026 Warnings and Precautions ( 5.1 ) 5/2026

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2632985
2632991

source batch

file

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

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

BLA761334

brand names

ZYNYZ

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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exact text: 1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell
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generic names

RETIFANLIMAB-DLWR

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exact text: is a programmed death receptor-1 (PD-1)–blocking antibody indicated
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qualifier mentions

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ment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
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exact text
metastatic squamous cell carcinoma of the a
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st-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
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recurrent or metastatic squamous cell carcin
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context exact
CAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
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first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC)
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context exact
indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
kind
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exact text
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exact text: 1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2291ad9008-46bd-4619-946f-75174fceaf56%22

spl effective date

2026-05-18

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

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

BLA761334

brand names

ZYNYZ

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

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exact text: (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinom
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generic names

RETIFANLIMAB-DLWR

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exact text: ( 1.1 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%2291ad9008-46bd-4619-946f-75174fceaf56%22

spl effective date

2026-05-18

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

unclear

Passage 3 · positive indication candidate

application numbers

BLA761334

brand names

ZYNYZ

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

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context span

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exact text: in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). ( 1.2 ) 1.1 Squamous Cell Carcinoma of the Anal Cana
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current approval status

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RETIFANLIMAB-DLWR

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exact text: is a programmed death receptor-1 (PD-1)–blocking antibody indicated
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qualifier mentions

context exact
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r the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
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exact text
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ngle agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
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exact text
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exact text: as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based 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

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structured indication

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

use intent

non_oncology_or_unclear_candidate

Passage 4 · positive indication candidate

application numbers

BLA761334

brand names

ZYNYZ

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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exact text: e anal canal (SCAC). ( 1.1 ) as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). ( 1.2 ) 1.1 Squamous Cell Carcinoma of the Anal Canal ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurr
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exact text: is a programmed death receptor-1 (PD-1)–blocking antibody indicated
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qualifier mentions

context exact
( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell c
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590
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ll Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
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metastatic or recurrent locally advanced Me
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ll Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
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exact text
metastatic or recurrent locally advanced Merk
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regulatory links

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( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
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fda indication exact
Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
fda source row index
7
fda source sha256
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source url
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exact text: ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
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source url

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spl effective date

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structured indication

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

use intent

tumor_directed_candidate

Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · unclassified context

application numbers

BLA761334

brand names

ZYNYZ

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exact text: on on or intolerance to platinum-based chemotherapy. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). ( 1.2 ) 1.1 Squamous Cell Carcinoma of the Anal Canal ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or m
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Read indication-specific status → · whole_fda_indication_text_present

Preserved source evidence · Not medical advice