LABELS · d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6

TEVIMBRA

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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: 2026-08-31
Captured: 2026-09-09T23:37:58.719708+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1). ( 1.2 ) Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy in adults for the first line treatment of HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. ( 1.3 ) 1.1 Esophageal Cancer First-Line Treatment of Esophageal Squamous Cell Carcinoma TEVIMBRA, in combination with platinum-containing chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). Previously Treated Esophageal Squamous Cell Carcinoma TEVIMBRA, as a single agent, is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. 1.2 Gastric Cancer TEVIMBRA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1). 1.3 Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma TEVIMBRA, in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma as detected by an FDA-authorized test [see Dosage and Administration (2.1) ].

Full extracted label fields

application numbers

BLA761232

boxed warning exact

brand names

TEVIMBRA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08ef1e3e-496f-4b0b-94ee-fbba3cc1985a

generic names

TISLELIZUMAB-JSGR

d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6

indications and usage exact

1 INDICATIONS AND USAGE TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1). ( 1.2 ) Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy in adults for the first line treatment of HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. ( 1.3 ) 1.1 Esophageal Cancer First-Line Treatment of Esophageal Squamous Cell Carcinoma TEVIMBRA, in combination with platinum-containing chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). Previously Treated Esophageal Squamous Cell Carcinoma TEVIMBRA, as a single agent, is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. 1.2 Gastric Cancer TEVIMBRA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1). 1.3 Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma TEVIMBRA, in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma as detected by an FDA-authorized test [see Dosage and Administration (2.1) ].

indications and usage tables exact

is original packager

true

manufacturer names

BeOne Medicines USA, Inc.

matched search terms

cancer
carcinoma
tumors

package ndcs

72579-121-01
72579-125-00

product ndcs

72579-121
72579-125

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.3 ) 8/2026 Dosage and Administration ( 2.1 ) 8/2026 Dosage and Administration ( 2.2 ) 8/2026 Dosage and Administration ( 2.4 ) 11/2025

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00600.json

Source passages and status connections

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

Passage 1 · positive indication candidate

application numbers

BLA761232

brand names

TEVIMBRA

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 TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastr
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current approval status

not_reconciled

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extraction review status

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generic names

TISLELIZUMAB-JSGR

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qualifier mentions

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context exact
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kind
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exact text
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context exact
phageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
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exact text
PD-L1 (≥1)
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context exact
ng chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
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exact text
unresectable or metastatic esophageal squamous
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kind
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exact text
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context exact
1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
kind
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exact text
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regulatory links

schema version

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source defined aliases

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exact text: 1 INDICATIONS AND USAGE TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6%22

spl effective date

2026-08-31

spl set id

08ef1e3e-496f-4b0b-94ee-fbba3cc1985a

spl version

structured fields status

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structured indication

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

use intent

tumor_directed_candidate

Passage 2 · unclassified context

application numbers

BLA761232

brand names

TEVIMBRA

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 530
end exclusive: true
exact text: in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cance
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start: 123

current approval status

not_reconciled

duplicate text group

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extraction review status

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generic names

TISLELIZUMAB-JSGR

ind-span-7cb9e9aa46b52ce1586f

label id

d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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exact text: ( 1.1 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22d46bfb2e-44c4-4a86-8a8f-b38fb01ac4b6%22

spl effective date

2026-08-31

spl set id

08ef1e3e-496f-4b0b-94ee-fbba3cc1985a

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

BLA761232

brand names

TEVIMBRA

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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end exclusive: true
exact text: ination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophag
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current approval status

not_reconciled

duplicate text group

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extraction review status

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generic names

TISLELIZUMAB-JSGR

ind-span-37fa8f96c0ca2742c26e

label id

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positive predicate support span

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qualifier mentions

context exact
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kind
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end
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exact text
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exact text
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exact text
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regulatory links

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source url

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spl effective date

2026-08-31

spl set id

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spl version

structured fields status

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structured indication

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

use intent

tumor_directed_candidate

Passage 4 · positive indication candidate

application numbers

BLA761232

brand names

TEVIMBRA

classification reasons

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clinical review status

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exact text: s PD-L1 (≥1). ( 1.1 ) as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. ( 1.1 ) Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1). ( 1.2 ) Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing chemotherapy in adults for the first line t
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qualifier mentions

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Preserved source evidence · Not medical advice