Drugs / Tucatinib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TUKYSA | — | 2023-01-19 | fda.gov ↗ |
| Approved | EU (EMA) | Tukysa | — | 2021-02-11 | europa.eu ↗ |
| Approved | US (FDA) | TUKYSA | — | 2020-04-17 | fda.gov ↗ |
Trials 61
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials · 1 met primary | ||||||
| Phase 1 | NCT05553522 | Jan 2024 → Dec 2025 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Baptist Health South Florida | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT06067776 | Jan 2024 → Jan 2025 overdue | non-small cell lung carcinoma | Jonathan Riess | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06162559 | Dec 2023 → Aug 2026 overdue | breast cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05382364 | Jun 2022 → Dec 2026 expected | HER2 positive breast carcinoma, colorectal cancer, gastroesophageal adenocarcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03846583 | Jun → Sep 2020 | breast cancer | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03914755 | May → Aug 2019 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03826602 | Feb → Mar 2019 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03777761 | Dec 2018 → Mar 2019 | — | Seagen Inc. | Completed | Met primary |
| Phase 1 | NCT03722823 | Oct 2018 → May 2019 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03723395 | Sep → Dec 2018 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03758339 | Dec 2017 → Jan 2018 | — | Cascadian Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02892123 | Sep 2016 → Oct 2024 | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01983501 | Feb 2014 → Oct 2017 | HER2 positive breast carcinoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02025192 | Dec 2013 → Oct 2017 | HER2 positive breast carcinoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00650572 | May 2008 → Mar 2013 | cancer | Seagen Inc. | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07494448 | Jul 2026 → Dec 2027 expected | HER2 positive breast carcinoma | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06686394 | Feb 2025 → Apr 2030 expected | breast cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05868226 | Feb 2023 → Dec 2030 expected | HER2 positive breast carcinoma, colon adenocarcinoma, hormone receptor-positive breast cancer, metastatic malignant neoplasm +2 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05230810 | Aug 2022 → Mar 2026 overdue | HER2 positive breast carcinoma | Criterium, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04512261 | Jun 2022 → Jun 2024 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Reva Basho | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05319873 | Apr 2022 → Apr 2027 expected | HER2 positive breast carcinoma, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05091528 | Feb → Jul 2022 | HER2 positive breast carcinoma, non-small cell lung carcinoma | Silverback Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04896320 | Dec 2021 → Jun 2023 | female breast carcinoma | Providence Health & Services | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04538742 | Dec 2020 → Jan 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03054363 | Nov 2017 → Jan 2023 | breast cancer | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 229 trials · 2 met primary | ||||||
| Phase 2 | NCT07193394 | Jan 2026 → Dec 2028 expected | Her2-receptor negative breast cancer | Institut Curie | Recruiting | No outcome recorded |
| Phase 2 | NCT06439693 | Aug 2024 → Mar 2030 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, female breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06157892 | May 2024 → Jul 2029 expected | HER2 positive breast carcinoma, gastric cancer, gastroesophageal junction adenocarcinoma, triple-negative breast carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05458674 | Jan 2024 → Jun 2027 expected | breast carcinoma by gene expression profile | Criterium, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05955170 | Dec 2023 → Dec 2027 expected | HER2 positive breast carcinoma | Institut Curie | Recruiting | No outcome recorded |
| Phase 2 | NCT05800275 | Dec 2023 → Dec 2026 expected | HER2 positive breast carcinoma, malignant leptomeningeal tumor, neoplastic meningitis | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06016387 | Nov 2023 → Dec 2026 expected | HER2 positive breast carcinoma | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT05356897 | Oct 2023 → Sep 2024 | colon adenocarcinoma, rectum adenocarcinoma | Academic and Community Cancer Research United | Withdrawn | No outcome recorded |
| Phase 2 | NCT05748834 | Jul 2023 → Nov 2027 expected | breast cancer | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT05062889 | May 2023 → Oct 2027 | malignant colon neoplasm | Gruppo Oncologico del Nord-Ovest | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05673928 | May 2023 → Mar 2027 expected | metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05892068 | May 2023 → May 2028 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05323955 | Mar 2023 → Nov 2026 expected | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Carey Anders, M.D. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05583110 | Mar 2023 → May 2025 | HER2 positive breast carcinoma | Spanish Breast Cancer Research Group | Terminated | No outcome recorded |
| Phase 2 | NCT04789096 | Mar 2023 → Jun 2025 | HER2 positive breast carcinoma | Breast Cancer Trials, Australia and New Zealand | Terminated | No outcome recorded |
| Phase 2 | NCT05672524 | Dec 2022 → Jul 2027 expected | rectum adenocarcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05041842 | Dec 2021 → Apr 2025 overdue | metastatic malignant neoplasm in the brain | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04760431 | Oct 2021 → Sep 2024 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT04721977 | Apr 2021 → Jul 2023 overdue | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632992 | Jan 2021 → Dec 2023 | cancer of unknown primary site | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04579380 | Jan 2021 → Nov 2023 overdue | biliary tract neoplasm, breast neoplasm, cervical cancer, non-small cell lung carcinoma +1 | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04539938 | Dec 2020 → Jul 2024 | HER2 positive breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04430738 | Sep 2020 → Jul 2024 overdue | cholangiocarcinoma, colorectal carcinoma, esophageal adenocarcinoma, gallbladder carcinoma +2 | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03501979 | Feb 2019 → Jun 2021 | breast cancer, neoplastic meningitis | University of Alabama at Birmingham | Terminated | Met primary Stop: Enrollment |
| Phase 2 | NCT03297606 | Mar 2018 → Dec 2026 expected | non-Hodgkin lymphoma, plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03043313 | Jun 2017 → Mar 2022 | colorectal adenocarcinoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | Mixed |
| Phase 2 | NCT02614794 | Jan 2016 → Sep 2019 | HER2 positive breast carcinoma | Seagen Inc. | Completed | Met primary |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04499924 | Mar 2021 → Apr 2024 | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT05253651 | Oct 2022 → Dec 2027 expected | colorectal neoplasm | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05132582 | Mar 2022 → Sep 2025 overdue | HER2 positive breast carcinoma | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT04457596 | Mar 2021 → Jan 2028 expected | HER2 positive breast carcinoma, invasive breast carcinoma, synchronous bilateral breast carcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03975647 | Oct 2019 → Jun 2023 overdue | HER2 positive breast carcinoma | Pfizer | Active not recruiting | Met primary |
| Phase not stated2 trials | ||||||
| — | NCT04220203 | — | HER2 positive breast carcinoma | Pfizer | Approved for marketing | No outcome recorded |
| — | NCT03424473 | — | — | Seagen Inc. | No longer available | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06239467 Background | Feb 2024 → Dec 2026 expected | breast cancer | OnKure, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01921335 Comparator | Aug 2013 → Mar 2018 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT05227131 Background | May 2022 → Oct 2024 | HER2 positive breast carcinoma | MedSIR | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05190445 Background | Nov 2021 → Feb 2023 overdue | carcinoma | Pieris Pharmaceuticals GmbH | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT07413939 Comparator | May 2026 → May 2029 expected | HER2 positive breast carcinoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | Pfizer | Regulatory Pfizer’s TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer pfizer.com ↗
Today's FDA approval marks the next chapter for TUKYSA, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment. |
| 2026-04-21 | Pfizer | Results Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026 pfizer.com ↗
These results support TUKYSA’s potential use as part of a chemotherapy-free, first-line maintenance strategy for HER2+ MBC. |
| 2025-12-10 | Pfizer | Results TUKYSA Added to First-Line Maintenance Therapy Extends Median Progression-Free Survival by Over 8 Months in Patients with HER2+ Metastatic Breast Cancer pfizer.com ↗
In HER2CLIMB-05, the median progression-free survival (PFS) was 24.9 months (95% CI: 21.3-not reached) in the TUKYSA arm and 16.3 months (95% CI:12.6-18.7) in the placebo arm, representing an extension in median PFS of 8.6 months. |
| 2025-10-14 | Pfizer | Results TUKYSA Combination Significantly Improves Progression-Free Survival as First-Line Maintenance in HER2+ Metastatic Breast Cancer in HER2CLIMB-05 Trial pfizer.com ↗
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in the TUKYSA arm versus the placebo arm. |
| 2024-04-29 | Pfizer | Results Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting pfizer.com ↗
An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive profile of TUKYSA in colorectal cancer. |
All press releases naming this drug 6 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tucatinib | “ONT-380 (tucatinib) is a potent selective inhibitor of HER2 with intracranial activity in preclinical models.” PMID 32461105 ↗ May 202065“Tucatinib: 300mg po Q12H” NCT04760431 ↗ “Drug: Tucatinib” NCT05583110 ↗ “Drug: Tucatinib” NCT02892123 ↗ |
| Known as | ARRY-380 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00650572 ↗ |
| Known as | Irbinitinib | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989868 ↗ |
| Known as | MK-7119 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989868 ↗ |
| Known as | ONT-380 | “A Phase 1, Open Label, Safety, Tolerability, and Pharmacokinetic Study of Tucatinib (ONT-380) in Healthy Japanese and Caucasian Subjects” NCT03914755 ↗4“ONT-380 (tucatinib) is a potent selective inhibitor of HER2 with intracranial activity in preclinical models.” PMID 32461105 ↗ May 2020 “Tucatinib (ONT-380) is a potent, highly selective, oral HER2 small molecule tyrosine kinase inhibitor (TKI)” NCT04789096 ↗ “Tucatinib (ONT-380) will be administered orally, twice per day on days 1-21 of each cycle.” NCT01983501 ↗ “Tucatinib (ONT-380)” NCT07193394 ↗ |
| Known as | Tukysa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989868 ↗ |
| Action | Inhibit | “HER2 inhibitor” NCT00650572 ↗ |
| Modality | Small molecule | “Tucatinib is a potent and selective oral HER2 tyrosine kinase inhibitor” PMID 29804905 ↗ May 2018 |
| Route | Oral | “oral” NCT00650572 ↗ |
| Target | ERBB2 | “Tucatinib is an oral, potent, human epidermal growth factor receptor 2 (HER2)-specific tyrosine kinase inhibitor (TKI) being developed as a novel treatment for...” PMID 29955792 ↗ Sep 2018 |