DISEASE & TREATMENT SETTING

Childhood Colorectal Cancer

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

Colorectal Cancer in children and adolescents

Source population: pediatric
Disease extent: Not part of this definition
Treatment line: Not part of this definition
Stage: Not part of this definition
Resectability: Not part of this definition

Biomarkers, prior therapy and derivation

molecular
prior therapy
derivation status: unresolved
derivation note: Derived from NCI topic(s): Childhood Colorectal Cancer. Strongest NCIt resolution: ambiguous. Entity-level scope; stage, biomarker and treatment line are not yet part of this definition.
source wording: Source null

6 more-specific settings

Study evidence for this setting

Find a linked studyHow it was found

0 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

No linked study matches these filters. This is a source-coverage gap, not evidence that there are no treatment options.

Indication-specific source history

Dated source events, not confirmation of current approval for every use of a drug.

2017-05-23 · Keytruda (pembrolizumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-4c00c193d253a73b
event date: 2017-05-23
event kind: accelerated-approval
drug or regimen: Keytruda (pembrolizumab)
source indication text: Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-487463a69affaee7e9a9
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2017-07-31 · Opdivo (nivolumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-4409d8b1e374063b
event date: 2017-07-31
event kind: accelerated-approval
drug or regimen: Opdivo (nivolumab)
source indication text: For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-57a457367471d7ab21dc
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2018-07-10 · Opdivo (nivolumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-64e13b41aa1562ae
event date: 2018-07-10
event kind: accelerated-approval
drug or regimen: Opdivo (nivolumab)
source indication text: In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-335053bbaa8edf682446
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2018-07-10 · Yervoy (ipilimumab) · accelerated approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-ca2a7a6994c78e58
event date: 2018-07-10
event kind: accelerated-approval
drug or regimen: Yervoy (ipilimumab)
source indication text: In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-fc7a77fddb7346c70882
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2023-03-28 · Keytruda (pembrolizumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-fe2dac66706b69dd
event date: 2023-03-28
event kind: traditional-approval
drug or regimen: Keytruda (pembrolizumab)
source indication text: Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-487463a69affaee7e9a9
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2025-04-08 · Opdivo (nivolumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-8db1d63d68c45a92
event date: 2025-04-08
event kind: traditional-approval
drug or regimen: Opdivo (nivolumab)
source indication text: For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-57a457367471d7ab21dc
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2025-04-08 · Opdivo (nivolumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-9bec1c50bb7a7bc1
event date: 2025-04-08
event kind: traditional-approval
drug or regimen: Opdivo (nivolumab)
source indication text: In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-335053bbaa8edf682446
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2025-04-08 · Yervoy (ipilimumab) · traditional approval

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: fda-c22e582b174c1578
event date: 2025-04-08
event kind: traditional-approval
drug or regimen: Yervoy (ipilimumab)
source indication text: In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
match phrase: colorectal cancer
match status: candidate
status category: verified_clinical_benefit
has date discrepancy: 0
source collection: fda-status-row
source key: fda-aa-fc7a77fddb7346c70882
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

2025-04-08 · nivolumab with ipilimumab · approval notification

release id: clinical-indications-draft-1
disease state id: ds-colorectal-cancer-pediatric
event id: notice-56eac7681d879044
event date: 2025-04-08
event kind: approval-notification
drug or regimen: nivolumab with ipilimumab
source indication text: FDA approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer . The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.
match phrase: colorectal cancer
match status: candidate
status category: Source null
has date discrepancy: 0
source collection: fda-approval-notice
source key: fda-b3dfa41ec820a8c2
source url: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-ipilimumab-unresectable-or-metastatic-msi-h-or-dmmr-colorectal-cancer
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Original event source →

Source relationships and population-mapping limitations

bindings

release id
clinical-indications-draft-1
disease state id
ds-colorectal-cancer-pediatric
binding id
ncit-C2955
source collection
ncit-concept
source key
C2955
source excerpt
Source null
match status
ambiguous
match note
Resolution status: ambiguous.
recorded at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colorectal-cancer-pediatric
binding id
ncit-C4978
source collection
ncit-concept
source key
C4978
source excerpt
Source null
match status
ambiguous
match note
Resolution status: ambiguous.
recorded at
2026-09-10T00:00:00Z

mappings

Download this complete draft source relationship record →

Preserved source evidence · Not medical advice