STATUS · fda-aa-57a457367471d7ab21dc

Opdivo (nivolumab)

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This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

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

Source status category: verified clinical benefit
Event date: 2025-04-08
Meaning of this date: FDA table traditional approval date

accelerated approval date

2017-07-31

accelerated approval date source text

7/31/2017

brand name hint

Opdivo

date change comparison status

no_previous_normalized_snapshot_supplied

date change from prior snapshot

Source null

drug name exact

Opdivo (nivolumab)

generic name hint

nivolumab

fda-aa-57a457367471d7ab21dc

indication exact

original projected completion source text

Source null

post marketing requirement exact

Source null

record type

fda_accelerated_approval_status_row

related fda urls

source cells exact

links
text
Opdivo (nivolumab)
links
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
links
text
7/31/2017
links
text
4/08/2025

source provenance

bytes: 74315
effective url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
file: /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
http status: 200
requested url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
retrieved at: 2026-09-09T23:35:16.058704+00:00
sha256: 91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
source page date Modified text: Wed, 07/15/2026 - 00:00
source page date Published text: Wed, 07/15/2026 - 07:11

source row index

source table headers

Drug Name
Accelerated Approval (AA) Indication
Accelerated Approval Date
Traditional Approval Date

source table index

source url

https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals

status applies to

This exact indication and regimen, not every use of this drug

status category

verified_clinical_benefit

status event date

2025-04-08

status event date meaning

FDA table traditional approval date

traditional approval date

2025-04-08

verification flags

verification status

official_fda_status_table_extracted_indication_matching_not_clinically_reviewed

withdrawal date

Source null

Source correspondence records

matching

drug name exact

Opdivo (nivolumab)

fda status record id

fda-aa-57a457367471d7ab21dc

indication exact

match status

source_correspondence_found_clinical_review_pending

matched candidate ids

ind-span-c792b5d70a7b8803741d

source provenance

bytes: 74315
effective url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
file: /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
http status: 200
requested url: https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
retrieved at: 2026-09-09T23:35:16.058704+00:00
sha256: 91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
source page date Modified text: Wed, 07/15/2026 - 00:00
source page date Published text: Wed, 07/15/2026 - 07:11

source url

https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals

status category

verified_clinical_benefit

unmatched meaning

Source null

links

package id
fda-label-library-8184721b7b3bb86692f8276c
correspondence id
correspondence-fe390728ebe83096fc908a3e
span id
ind-span-c792b5d70a7b8803741d
status id
fda-aa-57a457367471d7ab21dc
match method
whole_indication_literal_normalized_substring
scope relationship
whole_fda_indication_text_present
matching review status
source_comparison_only_clinical_review_pending
payload
candidate source span
end
10385
end exclusive
true
exact text
• OPDIVO, as a single agent, is indicated 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.
label id
1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
start
10065
fda indication exact
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
fda source row index
15
fda source sha256
91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
fda status record id
fda-aa-57a457367471d7ab21dc
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/verified-clinical-benefit-cancer-accelerated-approvals
status category
verified_clinical_benefit
status event date
2025-04-08
supporting anchor spans

Preserved source evidence · Not medical advice