Tucatinib
Also known as Tukysa
Seagen Inc. · Colorectal Neoplasms; Esophageal Adenocarcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; HER2 Positive Breast Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
Approved
NDA213411,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Seagen Inc. Source: Company record for Seagen Inc. (opens in a new tab)
- Indications
- Colorectal Neoplasms; Esophageal Adenocarcinoma; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; HER2 Positive Breast Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 213411 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 213411 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 22 Mar 20211 linked trial
- Phase 3 CompletedFirst trial start 2 Oct 20194 linked trials
- Filed Completed
- Approved Current stageFirst approval 17 Apr 2020
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Tucatinib. Editors add each one with its source.
Filed application
No filed application is on record for Tucatinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Tucatinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05253651ClinicalTrials.gov record for NCT05253651 (opens in a new tab)MOUNTAINEER-03 | A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer | Phase 3 | Recruiting | 400 (estimated) | 31 Dec 2027 (estimated) | No |
Publications listing MOUNTAINEER-03 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05132582ClinicalTrials.gov record for NCT05132582 (opens in a new tab)HER2CLIMB-05 | A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer | Phase 3 | Active, not recruiting | 654 (actual) | 5 Sep 2025 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05132582 (opens in a new tab) |
Posted results on ClinicalTrials.gov for HER2CLIMB-05
Serious adverse events (From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)): Tucatinib + Trastuzumab + Pertuzumab 55 of 326; Placebo + Trastuzumab + Pertuzumab 26 of 324 Source: ClinicalTrials.gov results for NCT05132582 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing HER2CLIMB-05 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04499924ClinicalTrials.gov record for NCT04499924 (opens in a new tab)MOUNTAINEER-02 | Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer | Phase 2/3 | Completed | 17 (actual) | 17 Apr 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04499924 (opens in a new tab) |
Posted results on ClinicalTrials.gov for MOUNTAINEER-02 Serious adverse events (From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum treatment duration= 19.8 months, maximum follow-up duration up to 20.8 months)): Paclitaxel 60 mg/m^2 4 of 8; Paclitaxel 80 mg/m^2 5 of 9 Source: ClinicalTrials.gov results for NCT04499924 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03975647ClinicalTrials.gov record for NCT03975647 (opens in a new tab) | A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer | Phase 3 | Active, not recruiting | 466 (actual) | 29 Jun 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03975647 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03975647
Serious adverse events (From start of treatment up to 30 days after the last study treatment (approximately 43 months)): Placebo+ Ado-trastuzumab Emtansine 52 of 233; Tucatinib+ Ado-trastuzumab Emtansine 70 of 231 Source: ClinicalTrials.gov results for NCT03975647 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03975647 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA213411Action letter for NDA213411 (opens in a new tab) | Supplement 10 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213411Action letter for NDA213411 (opens in a new tab) | Supplement 4 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213411Action letter for NDA213411 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Tukysa (EMEA/H/C/005263)
- Authorised
- Therapeutic area
- Breast Neoplasms;Neoplasm Metastasis
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Active substance (INN)
- tucatinib
- ATC code
- L01EH03
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Tukysa (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 213411 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05253651 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05132582 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04499924 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03975647 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA213411 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.