TriangleSTATUS · fda-aa-5a2bb9726cc98fa891b0
Tukysa (tucatinib)
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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
In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
- Source status category
- ongoing
- Event date
- 2023-01-19
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2023-01-19
- accelerated approval date source text
- 1/19/2023
- brand name hint
- Tukysa
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Tukysa (tucatinib)
- generic name hint
- tucatinib
- id
- fda-aa-5a2bb9726cc98fa891b0
- indication exact
- In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
- original projected completion source text
- 04/30/2026
- post marketing requirement exact
- 4388-1: Conduct a randomized clinical trial to obtain data on the clinical efficacy of tucatinib for patients with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma. The trial should compare tucatinib in combination with trastuzumab with the standard of care in patients with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma. The primary endpoint should be PFS per blinded assessment or OS. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma and allow for interpretation of the results across this representative study population.
- record type
- fda_accelerated_approval_status_row
- related fda urls
- source cells exact
- links
- text
- Tukysa (tucatinib)
- links
- /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tucatinib-trastuzumab-colorectal-cancer
- text
- In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
- links
- text
- 1/19/2023
- links
- text
- 4388-1: Conduct a randomized clinical trial to obtain data on the clinical efficacy of tucatinib for patients with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma. The trial should compare tucatinib in combination with trastuzumab with the standard of care in patients with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma. The primary endpoint should be PFS per blinded assessment or OS. The trial should enroll a sufficiently representative study population to reflect the racial and ethnic diversity of the U.S. patient population with RAS wild type, HER2-positive, unresectable or metastatic colorectal carcinoma and allow for interpretation of the results across this representative study population.
- links
- text
- 04/30/2026
- source provenance
- bytes
- 102185
- effective url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- file
- /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
- http status
- 200
- requested url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- retrieved at
- 2026-09-09T23:35:15.160724+00:00
- sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- source page date Modified text
- Wed, 09/09/2026 - 00:00
- source page date Published text
- Wed, 09/09/2026 - 12:45
- source row index
- 33
- source table headers
- Drug Name
- Accelerated Approval (AA) Indication
- AA Date
- AA Post-Marketing Requirement
- Original Projected Completion 1
- source table index
- 0
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- status applies to
- This exact indication and regimen, not every use of this drug
- status category
- ongoing
- status event date
- 2023-01-19
- status event date meaning
- Original accelerated approval date; ongoing status observed at source retrieval
- traditional approval date
- Source null
- 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
- Tukysa (tucatinib)
- fda status record id
- fda-aa-5a2bb9726cc98fa891b0
- indication exact
- In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-844709edcc7076ae5434
- ind-span-967c77a544cd119b4ad0
- source provenance
- bytes
- 102185
- effective url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- file
- /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
- http status
- 200
- requested url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- retrieved at
- 2026-09-09T23:35:15.160724+00:00
- sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- source page date Modified text
- Wed, 09/09/2026 - 00:00
- source page date Published text
- Wed, 09/09/2026 - 12:45
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- status category
- ongoing
- unmatched meaning
- Source null
- links
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-105c920e31593301cee3d257
- span id
- ind-span-967c77a544cd119b4ad0
- status id
- fda-aa-5a2bb9726cc98fa891b0
- 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
- 1560
- end exclusive
- true
- exact text
- 1.2 Unresectable or Metastatic Colorectal Cancer TUKYSA is indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
- label id
- 892c322b-be43-4180-89f7-4e3619a8b58f
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 60a06dbf088ef0ab8a97fe7ebd223d9f38c6b6c1bc1e1abaf60fdd9200908dd5
- start
- 1232
- fda indication exact
- In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
- fda source row index
- 33
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-5a2bb9726cc98fa891b0
- 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/ongoing-cancer-accelerated-approvals
- status category
- ongoing
- status event date
- 2023-01-19
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-75b44bb48d9587ed4f21b4b2
- span id
- ind-span-844709edcc7076ae5434
- status id
- fda-aa-5a2bb9726cc98fa891b0
- 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
- 615
- end exclusive
- true
- exact text
- • in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
- label id
- 892c322b-be43-4180-89f7-4e3619a8b58f
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 60a06dbf088ef0ab8a97fe7ebd223d9f38c6b6c1bc1e1abaf60fdd9200908dd5
- start
- 355
- fda indication exact
- In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
- fda source row index
- 33
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-5a2bb9726cc98fa891b0
- 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/ongoing-cancer-accelerated-approvals
- status category
- ongoing
- status event date
- 2023-01-19
- supporting anchor spans
Preserved source evidence · Not medical advice