LABELS · 892c322b-be43-4180-89f7-4e3619a8b58f

TUKYSA

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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: 2024-11-04
Captured: 2026-09-09T23:37:54.830918+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) • 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. ( 1.2 ) This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 1.1 Metastatic Breast Cancer TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. 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. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Full extracted label fields

application numbers

NDA213411

boxed warning exact

brand names

TUKYSA

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f27eb1b9-b7fc-424e-988f-84dd7bb195a3

generic names

TUCATINIB

892c322b-be43-4180-89f7-4e3619a8b58f

indications and usage exact

1 INDICATIONS AND USAGE TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) • 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. ( 1.2 ) This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 1.1 Metastatic Breast Cancer TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. 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. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

indications and usage tables exact

is original packager

true

manufacturer names

SEAGEN INC.

matched search terms

cancer
tumor

package ndcs

51144-001-60
51144-002-60
51144-002-12

product ndcs

51144-001
51144-002

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1.2 ) 1/2023 Patient Selection ( 2.1 ) 1/2023 Warnings and Precautions ( 5.1 ), ( 5.2 ) 1/2023

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2361296
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source batch

file

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

NDA213411

brand names

TUKYSA

classification reasons

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exact text: 1 INDICATIONS AND USAGE TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who
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exact text: 1 INDICATIONS AND USAGE TUKYSA is a kinase inhibitor indicated:
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source url

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spl effective date

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regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 2 · positive indication candidate

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brand names

TUKYSA

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exact text: 1 INDICATIONS AND USAGE TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) • 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 wit
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metastatic HER2-positive breast cancer
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exact text: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
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source url

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spl effective date

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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 3 · unclassified context

application numbers

NDA213411

brand names

TUKYSA

classification reasons

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clinical review status

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content role

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exact text: with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) • 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 fluoro
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source url

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tumor histology: Source null

use intent

unclear

Passage 4 · positive indication candidate

application numbers

NDA213411

brand names

TUKYSA

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exact text: anced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ( 1.1 ) • 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. ( 1.2 ) This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be co
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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
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current approval status

not_reconciled

duplicate text group

dup-b95085cfe8b10788b1bb

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generic names

TUCATINIB

ind-span-90f431b42ce2b0708b61

label id

892c322b-be43-4180-89f7-4e3619a8b58f

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

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source defined aliases

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exact text: This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ].
label id: 892c322b-be43-4180-89f7-4e3619a8b58f
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source url

https://api.fda.gov/drug/label.json?search=id%3A%22892c322b-be43-4180-89f7-4e3619a8b58f%22

spl effective date

2024-11-04

spl set id

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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

not_applicable

Passage 10 · approval contingency

application numbers

NDA213411

brand names

TUKYSA

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

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exact text: idine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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current approval status

not_reconciled

duplicate text group

dup-dc178971c04bbbf9e272

extraction review status

automated_candidate_pending_source_review

generic names

TUCATINIB

ind-span-6cd8dcfeb30b31088b1b

label id

892c322b-be43-4180-89f7-4e3619a8b58f

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

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source batch sha256

424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3

source defined aliases

source span

end: 1838
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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source text sha256: 60a06dbf088ef0ab8a97fe7ebd223d9f38c6b6c1bc1e1abaf60fdd9200908dd5
start: 1704

source url

https://api.fda.gov/drug/label.json?search=id%3A%22892c322b-be43-4180-89f7-4e3619a8b58f%22

spl effective date

2024-11-04

spl set id

f27eb1b9-b7fc-424e-988f-84dd7bb195a3

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

not_applicable

Preserved source evidence · Not medical advice