LABELS · 998985bb-7cd1-4e80-bd08-8fc7c503f982

EMRELIS

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: 2025-05-25
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

Full extracted label fields

application numbers

BLA761384

boxed warning exact

brand names

EMRELIS

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc04f980-3957-4e35-ab81-8ec2ffe87215

generic names

TELISOTUZUMAB VEDOTIN

998985bb-7cd1-4e80-bd08-8fc7c503f982

indications and usage exact

1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

AbbVie Inc.

matched search terms

cancer
tumor

package ndcs

0074-1044-01
0074-1055-01

product ndcs

0074-1044
0074-1055

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

2714245
2714251
2714253
2714255

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

BLA761384

brand names

EMRELIS

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: 578
end exclusive: true
exact text: 1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may b
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 0

current approval status

not_reconciled

duplicate text group

dup-4fb71846692efd86bf92

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-818d041f4f08917dcde7

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

end: 44
end exclusive: true
exact text: is indicated
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 32

qualifier mentions

context exact
CATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small
kind
age
polarity
not_inferred
span
end
80
end exclusive
true
exact text
adult patients
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
66
context exact
or the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high
kind
biomarker
polarity
not_inferred
span
end
116
end exclusive
true
exact text
metastatic
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
106
context exact
non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-app
kind
biomarker
polarity
not_inferred
span
end
221
end exclusive
true
exact text
Met protein overexpression [≥50% of tumor c
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
178
context exact
RELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high
kind
stage_or_setting
polarity
not_inferred
span
end
116
end exclusive
true
exact text
locally advanced or metastatic
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
86
context exact
FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy .
kind
prior_therapy_or_line
polarity
not_inferred
span
end
377
end exclusive
true
exact text
who have received a prior systemic therapy
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
334

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 378
end exclusive: true
exact text: 1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy .
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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 · approval contingency

application numbers

BLA761384

brand names

EMRELIS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 733
end exclusive: true
exact text: et protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibit
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 179

current approval status

not_reconciled

duplicate text group

dup-6e7de82dc95f55ceb2b1

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-41be5378e04c44c25bfe

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 533
end exclusive: true
exact text: This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] .
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 379

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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 3 · approval contingency

application numbers

BLA761384

brand names

EMRELIS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 872
end exclusive: true
exact text: who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSC
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 334

current approval status

not_reconciled

duplicate text group

dup-9b229b9f779f4a8d68a6

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-152a3b721becd9225a6e

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 672
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 534

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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 4 · positive indication candidate

application numbers

BLA761384

brand names

EMRELIS

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: 1246
end exclusive: true
exact text: d duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verific
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 473

current approval status

not_reconciled

duplicate text group

dup-3b91eead29cbaac3820a

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-fc404a5333ea91e781f3

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

end: 755
end exclusive: true
exact text: is a c-Met-directed antibody and microtubule inhibitor conjugate indicated
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 681

qualifier mentions

context exact
rotubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small
kind
age
polarity
not_inferred
span
end
791
end exclusive
true
exact text
adult patients
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
777
context exact
EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients
kind
biomarker
polarity
not_inferred
span
end
731
end exclusive
true
exact text
Met-directed antibody and microtubule inhib
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
688
context exact
or the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50%
kind
biomarker
polarity
not_inferred
span
end
860
end exclusive
true
exact text
metastatic non-squamous non-small cell lung
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
817
context exact
non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-app
kind
biomarker
polarity
not_inferred
span
end
931
end exclusive
true
exact text
Met protein overexpression [≥50% of tumor c
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
888
context exact
onjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpr
kind
stage_or_setting
polarity
not_inferred
span
end
848
end exclusive
true
exact text
locally advanced or metastatic non-squamous non-sma
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
797
context exact
rong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
kind
prior_therapy_or_line
polarity
not_inferred
span
end
1045
end exclusive
true
exact text
who have received a prior systemic therapy
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
1003

regulatory links

candidate source span
end
1046
end exclusive
true
exact text
EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
673
fda indication exact
Treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
fda source row index
13
fda source sha256
8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
fda status record id
fda-aa-1bdc47f45493f905a5e7
interpretation
Source wording correspondence to a dated FDA status row; current approval not certified
match method
whole_indication_literal_normalized_substring
matching review status
source_comparison_only_clinical_review_pending
scope relationship
whole_fda_indication_text_present
source url
https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
status category
ongoing
status event date
2025-05-14
supporting anchor spans

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 1046
end exclusive: true
exact text: EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 673

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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

Read indication-specific status → · whole_fda_indication_text_present

Passage 5 · approval contingency

application numbers

BLA761384

brand names

EMRELIS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1321
end exclusive: true
exact text: all cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 847

current approval status

not_reconciled

duplicate text group

dup-9a35c279d9f60bf95431

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-1215c45c33a6a28d8073

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 1176
end exclusive: true
exact text: ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR).
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 1047

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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 6 · approval contingency

application numbers

BLA761384

brand names

EMRELIS

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 1321
end exclusive: true
exact text: by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 977

current approval status

not_reconciled

duplicate text group

dup-9b229b9f779f4a8d68a6

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-d17f56d53784fe1d6a8a

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 1315
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 1177

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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 7 · unclassified context

application numbers

BLA761384

brand names

EMRELIS

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1321
end exclusive: true
exact text: overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 1116

current approval status

not_reconciled

duplicate text group

dup-6ca0eddf8e18bdd1e9d9

extraction review status

automated_candidate_pending_source_review

generic names

TELISOTUZUMAB VEDOTIN

ind-span-1e4b25999a5c85f34987

label id

998985bb-7cd1-4e80-bd08-8fc7c503f982

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
165
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start
131

source span

end: 1321
end exclusive: true
exact text: ( 1 )
label id: 998985bb-7cd1-4e80-bd08-8fc7c503f982
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: c0b8229a15154a668256503e442a96c9d8633cd869825a6c1576bfd760a0cdaf
start: 1316

source url

https://api.fda.gov/drug/label.json?search=id%3A%22998985bb-7cd1-4e80-bd08-8fc7c503f982%22

spl effective date

2025-05-25

spl set id

bc04f980-3957-4e35-ab81-8ec2ffe87215

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

Preserved source evidence · Not medical advice