LABELS · 36941d95-638d-4a3c-8888-209eea0e0722

MEKTOVI

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: 2025-03-20
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKTOVI is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . 1.2 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) MEKTOVI is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. [see Dosage and Administration (2.1) ] .

Full extracted label fields

application numbers

NDA210498

boxed warning exact

brand names

MEKTOVI

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c3408ac-d401-4925-8a03-26591afbc240

generic names

BINIMETINIB

36941d95-638d-4a3c-8888-209eea0e0722

indications and usage exact

1 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKTOVI is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . 1.2 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) MEKTOVI is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. [see Dosage and Administration (2.1) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Array BioPharma Inc.

matched search terms

cancer
melanoma

package ndcs

70255-010-02
70255-010-03

product ndcs

70255-010

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

2049127
2049133

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 · indication intro context

application numbers

NDA210498

brand names

MEKTOVI

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

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end: 264
end exclusive: true
exact text: 1 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in
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source field: indications_and_usage_exact
source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
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current approval status

not_reconciled

duplicate text group

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extraction review status

automated_candidate_pending_source_review

generic names

BINIMETINIB

ind-span-9b5fb6aa3effcdf7166a

label id

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positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
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source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
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qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

abbreviation
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definition exact
non-small cell lung cancer
definition span
end
380
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source span

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exact text: 1 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated:
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source field: indications_and_usage_exact
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start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2236941d95-638d-4a3c-8888-209eea0e0722%22

spl effective date

2025-03-20

spl set id

6c3408ac-d401-4925-8a03-26591afbc240

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 2 · positive indication candidate

application numbers

NDA210498

brand names

MEKTOVI

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: 444
end exclusive: true
exact text: 1 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test
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source array index: 0
source field: indications_and_usage_exact
source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
start: 0

current approval status

not_reconciled

duplicate text group

dup-11f2b8e225770f317fd2

extraction review status

automated_candidate_pending_source_review

generic names

BINIMETINIB

ind-span-c2de06d1a11f5ed6f52e

label id

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positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
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source array index: 0
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source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
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qualifier mentions

context exact
rafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
kind
biomarker
polarity
not_inferred
span
end
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end exclusive
true
exact text
metastatic melanoma with a BRAF V600E or V6
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source text sha256
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start
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context exact
nation with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved tes
kind
stage_or_setting
polarity
not_inferred
span
end
182
end exclusive
true
exact text
unresectable or metastatic melanoma with a BRAF
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offset unit
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source array index
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source field
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source text sha256
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context exact
• in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
kind
regimen
polarity
not_inferred
span
end
243
end exclusive
true
exact text
in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
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offset unit
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source field
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source text sha256
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start
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regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
380
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
36941d95-638d-4a3c-8888-209eea0e0722
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source array index
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source field
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source text sha256
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start
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source span

end: 244
end exclusive: true
exact text: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
label id: 36941d95-638d-4a3c-8888-209eea0e0722
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source array index: 0
source field: indications_and_usage_exact
source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
start: 65

source url

https://api.fda.gov/drug/label.json?search=id%3A%2236941d95-638d-4a3c-8888-209eea0e0722%22

spl effective date

2025-03-20

spl set id

6c3408ac-d401-4925-8a03-26591afbc240

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 3 · unclassified context

application numbers

NDA210498

brand names

MEKTOVI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 458
end exclusive: true
exact text: nhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1
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current approval status

not_reconciled

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extraction review status

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generic names

BINIMETINIB

ind-span-a2738c417a622864f96c

label id

36941d95-638d-4a3c-8888-209eea0e0722

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

abbreviation
NSCLC
definition exact
non-small cell lung cancer
definition span
end
380
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
label id
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offset unit
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source array index
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source field
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source text sha256
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source span

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end exclusive: true
exact text: ( 1.1 , 2.1 )
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
start: 245

source url

https://api.fda.gov/drug/label.json?search=id%3A%2236941d95-638d-4a3c-8888-209eea0e0722%22

spl effective date

2025-03-20

spl set id

6c3408ac-d401-4925-8a03-26591afbc240

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 4 · positive indication candidate

application numbers

NDA210498

brand names

MEKTOVI

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: 645
end exclusive: true
exact text: ated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKTOVI is indicated, in combination with encorafenib, for the treatment of patients with unresectable or m
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offset unit: unicode_code_points
source array index: 0
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current approval status

not_reconciled

duplicate text group

dup-e0201cb96712da94506e

extraction review status

automated_candidate_pending_source_review

generic names

BINIMETINIB

ind-span-0574b44747c0a0417bb2

label id

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positive predicate support span

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end exclusive: true
exact text: is a kinase inhibitor indicated
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qualifier mentions

context exact
• in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a B
kind
age
polarity
not_inferred
span
end
329
end exclusive
true
exact text
adult patients
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source field
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context exact
with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approve
kind
biomarker
polarity
not_inferred
span
end
378
end exclusive
true
exact text
metastatic non-small cell lung cancer (NSCL
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context exact
s with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
kind
biomarker
polarity
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span
end
407
end exclusive
true
exact text
BRAF V600E mutation
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context exact
with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved
kind
stage_or_setting
polarity
not_inferred
span
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380
end exclusive
true
exact text
metastatic non-small cell lung cancer (NSCLC)
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source field
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source text sha256
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context exact
• in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
kind
regimen
polarity
not_inferred
span
end
440
end exclusive
true
exact text
in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved
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source text sha256
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regulatory links

schema version

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source batch sha256

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source defined aliases

abbreviation
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definition exact
non-small cell lung cancer
definition span
end
380
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source field
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source span

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end exclusive: true
exact text: • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
label id: 36941d95-638d-4a3c-8888-209eea0e0722
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
start: 259

source url

https://api.fda.gov/drug/label.json?search=id%3A%2236941d95-638d-4a3c-8888-209eea0e0722%22

spl effective date

2025-03-20

spl set id

6c3408ac-d401-4925-8a03-26591afbc240

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 5 · unclassified context

application numbers

NDA210498

brand names

MEKTOVI

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 659
end exclusive: true
exact text: 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKTOVI is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic mela
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
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start: 246

current approval status

not_reconciled

duplicate text group

dup-b95d85e7eb453d57e12c

extraction review status

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generic names

BINIMETINIB

ind-span-4e7db79a5ab5666145f5

label id

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positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

abbreviation
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definition exact
non-small cell lung cancer
definition span
end
380
end exclusive
true
exact text
non-small cell lung cancer (NSCLC)
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source field
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source text sha256
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start
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source span

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exact text: ( 1.2 , 2.1 )
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source text sha256: b59e6fb9659cd513e16ea20b0f5993c717e9bcf2702450968f242c15933da20e
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source url

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exact text: in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKTOVI is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . 1.2 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) MEKTOVI is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cel
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Preserved source evidence · Not medical advice