Asset profile

tucatinib · Pfizer (PFE)

Indication: maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction
Also known as: TUKYSA, TUKYSA regimen

Company

Pfizer is one of the world's largest pharmaceutical firms, with annual sales of roughly $60 billion. While it historically sold many types of healthcare products and chemicals, now prescription drugs and vaccines account for the majority of sales. Top sellers …

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On the calendar

Nov 2026

~ Nov 2026

PFEPfizer

tucatinib: Phase 2 trial NCT05323955 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2026

~ Dec 2026

PFEPfizer

tucatinib: Phase 2 trial NCT05800275 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Mar 2027

Mar 1, 2027

in 129 days

PFEPfizer

tucatinib: Phase 2 trial NCT05673928 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Apr 2027

Apr 1, 2027

in 160 days

PFEPfizer

tucatinib: Phase 1/Phase 2 trial NCT05319873 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Oct 2027

~ Oct 2027

PFEPfizer

tucatinib: Phase 2 trial NCT05062889 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2027

Dec 31, 2027

in 434 days

PFEPfizer

tucatinib: Phase 3 trial NCT05253651 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

May 2028

May 9, 2028

in 564 days

PFEPfizer

tucatinib: Phase 2 trial NCT05892068 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Timeline

Newest first.

Oct 7, 2026

04:57 PM

PFEPfizer

Pfizer TUKYSA (tucatinib) Receives FDA Approval for Front-Line Maintenance in HER2+ Metastatic Breast Cancer

FDA approvalCompany press release Open record1 update

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 7, 2026

Primary endpoint metUnknown

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

515 of 1044 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

Seagen Not US-listedPartner

PFEPfizerOwner

Company press release Oct 7, 2026
FDA announcement Oct 8, 2026

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT05673928	Phase 2	Recruiting	Mar 1, 2027	30	1 of 1 sites in the United States
NCT05323955	Phase 2	Active, not recruiting	Nov 1, 2026	48	8 of 8 sites in the United States
NCT03975647	Phase 3	Active, not recruiting	Jun 29, 2023	466	321 of 490 sites in the United States
NCT04512261	Phase 1/2	Withdrawn	Jun 1, 2024	0	1 of 1 sites in the United States
NCT05253651	Phase 3	Recruiting	Dec 31, 2027	400	132 of 366 sites in the United States
NCT05800275	Phase 2	Recruiting	Dec 1, 2026	30	0 of 11 sites in the United States
NCT03501979	Phase 2	Terminated	Jun 22, 2021	17	9 of 9 sites in the United States
NCT04538742	Phase 1/2	Active, not recruiting	Jan 31, 2025	245	10 of 72 sites in the United States
NCT04430738	Phase 2	Active, not recruiting	Jul 31, 2024	40	21 of 27 sites in the United States
NCT05583110	Phase 2	Terminated	May 30, 2025	13	0 of 18 sites in the United States
NCT05892068	Phase 2	Active, not recruiting	May 9, 2028	9	7 of 7 sites in the United States
NCT05062889	Phase 2	Suspended	Oct 1, 2027	477	0 of 28 sites in the United States
NCT05190445	Phase 2	Active, not recruiting	Feb 1, 2023	80	4 of 5 sites in the United States
NCT05319873	Phase 1/2	Active, not recruiting	Apr 1, 2027	18	1 of 1 sites in the United States

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