LABELS · 59075332-49ef-4998-98c4-81e61f57d424

Cotellic

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: 2026-07-29
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.

Full extracted label fields

application numbers

NDA206192

boxed warning exact

brand names

Cotellic

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c387579e-cee0-4334-bd1e-73f93ac1bde6

generic names

COBIMETINIB

59075332-49ef-4998-98c4-81e61f57d424

indications and usage exact

1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.

indications and usage tables exact

is original packager

true

manufacturer names

Genentech, Inc.

matched search terms

melanoma
neoplasms

package ndcs

50242-717-01

product ndcs

50242-717

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 300
total: 830

terms

https://open.fda.gov/terms/

sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259075332-49ef-4998-98c4-81e61f57d424%22

spl effective date

2026-07-29

spl effective time

20260729

spl set id

c387579e-cee0-4334-bd1e-73f93ac1bde6

spl version

substance names

COBIMETINIB FUMARATE

uniis

6EXI96H8SV

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA206192
payload
all indexed label documents
Appl No
206192
Application Docs Date
2015-11-10 00:00:00
Application Docs ID
19708
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
206192
Application Docs Date
2016-06-01 00:00:00
Application Docs ID
40528
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf
Submission No
1
Submission Type
SUPPL
Appl No
206192
Application Docs Date
2018-01-30 00:00:00
Application Docs ID
52086
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206192s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
206192
Application Docs Date
2022-07-29 00:00:00
Application Docs ID
71666
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s004lbl.pdf
Submission No
4
Submission Type
SUPPL
Appl No
206192
Application Docs Date
2022-10-31 00:00:00
Application Docs ID
72495
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s005lbl.pdf
Submission No
5
Submission Type
SUPPL
Appl No
206192
Application Docs Date
2023-06-01 00:00:00
Application Docs ID
74424
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206192s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
206192
Application Docs Date
2026-08-25 00:00:00
Application Docs ID
87024
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206192s007lbl.pdf
Submission No
7
Submission Type
SUPPL
all submission records
Appl No
206192
Review Priority
PRIORITY
Submission Class Code ID
7
Submission No
1
Submission Status
AP
Submission Status Date
2015-11-10 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
206192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
1
Submission Status
AP
Submission Status Date
2016-05-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
206192
Review Priority
STANDARD
Submission Class Code ID
2
Submission No
2
Submission Status
AP
Submission Status Date
2018-01-26 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
206192
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
4
Submission Status
AP
Submission Status Date
2022-07-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
206192
Review Priority
PRIORITY
Submission Class Code ID
2
Submission No
5
Submission Status
AP
Submission Status Date
2022-10-28 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
206192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2023-05-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
206192
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
7
Submission Status
AP
Submission Status Date
2026-08-20 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA206192
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206192
has approved submission record
true
latest approved submission date
2026-08-20
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
206192
Application Docs Date
2026-08-25 00:00:00
Application Docs ID
87024
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206192s007lbl.pdf
Submission No
7
Submission Type
SUPPL
official application record
Appl No
206192
Appl Public Notes
Appl Type
NDA
Sponsor Name
GENENTECH INC
openfda application present
true
products
Active Ingredient
COBIMETINIB FUMARATE
Appl No
206192
Drug Name
COTELLIC
Form
TABLET;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 20MG BASE
marketing status
Prescription

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

NDA206192

brand names

Cotellic

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: 414
end exclusive: true
exact text: 1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of ad
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 0

current approval status

not_reconciled

duplicate text group

dup-b2811a822be592e7ecef

extraction review status

automated_candidate_pending_source_review

generic names

COBIMETINIB

ind-span-1890afdbe56a50e44ba1

label id

59075332-49ef-4998-98c4-81e61f57d424

positive predicate support span

end: 66
end exclusive: true
exact text: is a kinase inhibitor indicated
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 35

qualifier mentions

context exact
LIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E
kind
age
polarity
not_inferred
span
end
103
end exclusive
true
exact text
adult patients
label id
59075332-49ef-4998-98c4-81e61f57d424
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unicode_code_points
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source field
indications_and_usage_exact
source text sha256
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start
89
context exact
d: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
kind
biomarker
polarity
not_inferred
span
end
168
end exclusive
true
exact text
metastatic melanoma with a BRAF V600E or V6
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
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start
125
context exact
hibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
kind
stage_or_setting
polarity
not_inferred
span
end
156
end exclusive
true
exact text
unresectable or metastatic melanoma with a BRAF
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
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start
109
context exact
or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
kind
regimen
polarity
not_inferred
span
end
213
end exclusive
true
exact text
in combination with vemurafenib
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start
182

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 214
end exclusive: true
exact text: 1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259075332-49ef-4998-98c4-81e61f57d424%22

spl effective date

2026-07-29

spl set id

c387579e-cee0-4334-bd1e-73f93ac1bde6

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 · positive indication candidate

application numbers

NDA206192

brand names

Cotellic

classification reasons

inherited_predicate_from_same_label_section_requires_review
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 511
end exclusive: true
exact text: ND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in com
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 15

current approval status

not_reconciled

duplicate text group

dup-f3bda0bc49ee63b79a12

extraction review status

automated_candidate_pending_source_review

generic names

COBIMETINIB

ind-span-5e6721953fb560b51de4

label id

59075332-49ef-4998-98c4-81e61f57d424

positive predicate support span

end: 66
end exclusive: true
exact text: is a kinase inhibitor indicated
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 35

qualifier mentions

context exact
( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms.
kind
age
polarity
not_inferred
span
end
283
end exclusive
true
exact text
adult patients
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start
269
context exact
( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms.
kind
regimen
polarity
not_inferred
span
end
310
end exclusive
true
exact text
As a single agent for the treatment of adult patients with histiocytic neoplasms
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
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source array index
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source field
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source text sha256
98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start
230

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 311
end exclusive: true
exact text: ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms.
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 215

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259075332-49ef-4998-98c4-81e61f57d424%22

spl effective date

2026-07-29

spl set id

c387579e-cee0-4334-bd1e-73f93ac1bde6

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

non_oncology_or_unclear_candidate

Passage 3 · unclassified context

application numbers

NDA206192

brand names

Cotellic

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 526
end exclusive: true
exact text: esectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with v
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 112

current approval status

not_reconciled

duplicate text group

dup-d4eee577a70c50a56819

extraction review status

automated_candidate_pending_source_review

generic names

COBIMETINIB

ind-span-9bbb1982d1a38d71512f

label id

59075332-49ef-4998-98c4-81e61f57d424

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 326
end exclusive: true
exact text: ( 1.2 , 14.2 )
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 312

source url

https://api.fda.gov/drug/label.json?search=id%3A%2259075332-49ef-4998-98c4-81e61f57d424%22

spl effective date

2026-07-29

spl set id

c387579e-cee0-4334-bd1e-73f93ac1bde6

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

NDA206192

brand names

Cotellic

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: 670
end exclusive: true
exact text: tastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
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source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 127

current approval status

not_reconciled

duplicate text group

dup-db3745631d387ab9c0b3

extraction review status

automated_candidate_pending_source_review

generic names

COBIMETINIB

ind-span-1b61f21450fc9afb6a54

label id

59075332-49ef-4998-98c4-81e61f57d424

positive predicate support span

end: 390
end exclusive: true
exact text: is indicated
label id: 59075332-49ef-4998-98c4-81e61f57d424
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 98fa8c17adf680b109d2deb5b1047a98413d3d6426dc179b68b624047cd2737a
start: 378

qualifier mentions

context exact
tatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E
kind
age
polarity
not_inferred
span
end
426
end exclusive
true
exact text
adult patients
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
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source array index
0
source field
indications_and_usage_exact
source text sha256
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start
412
context exact
1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or me
kind
biomarker
polarity
not_inferred
span
end
390
end exclusive
true
exact text
Metastatic Melanoma COTELLIC ® is indicated
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
unicode_code_points
source array index
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source field
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source text sha256
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start
347
context exact
ed for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
kind
biomarker
polarity
not_inferred
span
end
491
end exclusive
true
exact text
metastatic melanoma with a BRAF V600E or V6
label id
59075332-49ef-4998-98c4-81e61f57d424
offset unit
unicode_code_points
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Preserved source evidence · Not medical advice