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STATUS · fda-aa-75af3fe3afd64dda1ccc

Krazati (adagrasib)

Open original source → · Download preserved record

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

In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Source status category
withdrawn
Event date
2026-09-01
Meaning of this date
FDA table withdrawal date
accelerated approval date
2024-06-01
accelerated approval date source text
6/1/2024
brand name hint
Krazati
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
date discrepancy
explanation
FDA withdrawal table prints a different original accelerated-approval date from the linked original FDA notice. Both preserved; this discrepancy does not change the source-reported withdrawal date.
field
accelerated_approval_date
original fda notice file
/private/tmp/cancer-full-research/indications/raw/krazati-original-approval.html
original fda notice sha256
df199bc09063a49782bfa6698afde3f973a93c8bc78c01e01f6908a313a2b33c
original fda notice value
2024-06-21
status table value
2024-06-01
drug name exact
Krazati (adagrasib)
generic name hint
adagrasib
id
fda-aa-75af3fe3afd64dda1ccc
indication exact
In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
original projected completion source text
Source null
post marketing requirement exact
Source null
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer
source cells exact
  1. links
      text
      Krazati (adagrasib)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer
      text
      In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
    2. links
        text
        6/1/2024
      1. links
          text
          9/1/2026
        source provenance
        bytes
        47132
        file
        /private/tmp/cancer-full-research/indications/raw/accelerated-withdrawn.html
        http status
        200
        retrieved at
        2026-09-09T23:35:14.026405+00:00
        sha256
        89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
        source page date Modified text
        Wed, 09/02/2026 - 00:00
        source page date Published text
        Wed, 09/02/2026 - 13:55
        source row index
        1
        source table headers
        1. Drug Name
        2. Accelerated Approval (AA) Indication
        3. Accelerated Approval Date
        4. Withdrawal Date 1
        source table index
        0
        source url
        https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
        status applies to
        This exact indication and regimen, not every use of this drug
        status category
        withdrawn
        status event date
        2026-09-01
        status event date meaning
        FDA table withdrawal date
        traditional approval date
        Source null
        verification flags
        1. accelerated_approval_date_conflicts_with_original_fda_notice
        verification status
        official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
        withdrawal date
        2026-09-01
        Source correspondence records
        matching
        drug name exact
        Krazati (adagrasib)
        fda status record id
        fda-aa-75af3fe3afd64dda1ccc
        indication exact
        In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
        match status
        source_correspondence_found_clinical_review_pending
        matched candidate ids
        1. ind-span-9828ffdb49072d2d9fb1
        2. ind-span-a502dbd20bee607b93ed
        source provenance
        bytes
        47132
        file
        /private/tmp/cancer-full-research/indications/raw/accelerated-withdrawn.html
        http status
        200
        retrieved at
        2026-09-09T23:35:14.026405+00:00
        sha256
        89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
        source page date Modified text
        Wed, 09/02/2026 - 00:00
        source page date Published text
        Wed, 09/02/2026 - 13:55
        status category
        withdrawn
        unmatched meaning
        Source null
        links
        1. package id
          fda-label-library-8184721b7b3bb86692f8276c
          correspondence id
          correspondence-4806ac8fd00bc9460e799b09
          span id
          ind-span-9828ffdb49072d2d9fb1
          status id
          fda-aa-75af3fe3afd64dda1ccc
          match method
          targeted_literal_constraint_correspondence
          scope relationship
          same_indication_constraints_source_compared_NSCLC_not_included
          matching review status
          source_comparison_only_clinical_review_pending
          payload
          candidate source span
          end
          642
          end exclusive
          true
          exact text
          • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
          label id
          65724d4c-78ab-4d85-83b5-73b9da5c2cc3
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
          start
          369
          fda indication exact
          In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
          fda source row index
          1
          fda source sha256
          89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
          fda status record id
          fda-aa-75af3fe3afd64dda1ccc
          interpretation
          Potential stale-label conflict for this indication
          match method
          targeted_literal_constraint_correspondence
          matching review status
          source_comparison_only_clinical_review_pending
          scope relationship
          same_indication_constraints_source_compared_NSCLC_not_included
          status category
          withdrawn
          status event date
          2026-09-01
          supporting anchor spans
          1. end
            400
            end exclusive
            true
            exact text
            cetuximab
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
            391
          2. end
            452
            end exclusive
            true
            exact text
            KRAS G12C
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            443
          3. end
            477
            end exclusive
            true
            exact text
            locally advanced
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            461
          4. end
            491
            end exclusive
            true
            exact text
            metastatic
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            481
          5. end
            495
            end exclusive
            true
            exact text
            CRC
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            492
          6. end
            592
            end exclusive
            true
            exact text
            fluoropyrimidine-
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            575
          7. end
            606
            end exclusive
            true
            exact text
            oxaliplatin-
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            594
          8. end
            641
            end exclusive
            true
            exact text
            irinotecan-based chemotherapy
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            612
          9. end
            437
            end exclusive
            true
            exact text
            adult patients
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            423
        2. package id
          fda-label-library-8184721b7b3bb86692f8276c
          correspondence id
          correspondence-bd2a656dcc140a1bd62dc81e
          span id
          ind-span-a502dbd20bee607b93ed
          status id
          fda-aa-75af3fe3afd64dda1ccc
          match method
          targeted_literal_constraint_correspondence
          scope relationship
          same_indication_constraints_source_compared_NSCLC_not_included
          matching review status
          source_comparison_only_clinical_review_pending
          payload
          candidate source span
          end
          2032
          end exclusive
          true
          exact text
          1.2 KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
          label id
          65724d4c-78ab-4d85-83b5-73b9da5c2cc3
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
          start
          1610
          fda indication exact
          In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
          fda source row index
          1
          fda source sha256
          89673e1cbbd3c99528562ed4e81dbddd21934fae5bef3b146d364754a9fbf5ed
          fda status record id
          fda-aa-75af3fe3afd64dda1ccc
          interpretation
          Potential stale-label conflict for this indication
          match method
          targeted_literal_constraint_correspondence
          matching review status
          source_comparison_only_clinical_review_pending
          scope relationship
          same_indication_constraints_source_compared_NSCLC_not_included
          status category
          withdrawn
          status event date
          2026-09-01
          supporting anchor spans
          1. end
            1718
            end exclusive
            true
            exact text
            cetuximab
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1709
          2. end
            1623
            end exclusive
            true
            exact text
            KRAS G12C
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1614
          3. end
            1648
            end exclusive
            true
            exact text
            Locally Advanced
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1632
          4. end
            1662
            end exclusive
            true
            exact text
            Metastatic
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1652
          5. end
            1680
            end exclusive
            true
            exact text
            Colorectal Cancer
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1663
          6. end
            1982
            end exclusive
            true
            exact text
            fluoropyrimidine-
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1965
          7. end
            1996
            end exclusive
            true
            exact text
            oxaliplatin-
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            1984
          8. end
            2031
            end exclusive
            true
            exact text
            irinotecan-based chemotherapy
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            9b6c241f56dc0f3b6918624f327b0c390b0f525ddf139ce064ecb06c19e67628
            start
            2002
          9. end
            1767
            end exclusive
            true
            exact text
            adult patients
            label id
            65724d4c-78ab-4d85-83b5-73b9da5c2cc3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
            1753

        Preserved source evidence · Not medical advice