Drugs / Brigatinib
Brigatinib
also known as
ALUNBRIG · AP26113 · AP261136 · BRIGATINIB (AP-26113) · BRIGATINIBAP-26113AP26113CS-4278
Small molecule targets ALK, EGFR, ROS1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | ALUNBRIG | — | 2018-12-21 – 2022-02-28 | fda.gov ↗ |
| Approved | EU (EMA) | Alunbrig | — | 2018-11-22 | europa.eu ↗ |
| Approved | US (FDA) | ALUNBRIG | — | 2017-04-28 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06132867 | Dec 2023 → Feb 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04227028 | Mar 2020 → Mar 2027 expected | non-small cell lung carcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04005144 | Feb 2020 → Oct 2022 | non-small cell lung carcinoma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 1 | NCT03420742 | Jun 2019 → Mar 2020 | non-small cell lung carcinoma | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03707938 | Dec 2018 → Jan 2026 overdue | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04925609 | Aug 2022 → Dec 2033 expected | ALK-positive anaplastic large cell lymphoma, inflammatory myofibroblastic tumor | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04260009 | Sep 2020 → Sep 2023 | ALK-positive anaplastic large cell lymphoma, inflammatory myofibroblastic tumor | Takeda | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01449461 | Sep 2011 → Nov 2015 | anaplastic large cell lymphoma, non-small cell lung carcinoma | Ariad Pharmaceuticals | Completed | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06522360 | Dec 2024 → Apr 2025 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05718297 | Jun → Sep 2024 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Withdrawn | No outcome recorded |
| Phase 2 | NCT05361564 | Jun 2022 → Jun 2024 | non-small cell lung carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05200481 | May 2022 → Sep 2025 overdue | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05014464 | Nov 2021 → Jun 2026 overdue | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04634110 | Nov 2020 → Apr 2022 | lung cancer, metastatic malignant neoplasm in the brain | University of Colorado, Denver | Terminated | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | No outcome recorded |
| Phase 2 | NCT04374305 | Jun 2020 → Dec 2029 expected | NF2-related schwannomatosis, acoustic neuroma, ependymoma, meningioma | Scott R. Plotkin, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT04074993 | May 2020 → Jan 2025 | non-small cell lung carcinoma | Ji-youn Han | Unknown | No outcome recorded |
| Phase 2 | NCT04223596 | May 2020 → Nov 2026 expected | non-small cell lung carcinoma | Fundación GECP | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04318938 | Mar 2020 → May 2026 | non-small cell lung carcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Completed | No outcome recorded |
| Phase 2 | NCT03737994 | Jul 2019 → Jul 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT03868423 | Mar 2019 → Nov 2020 | high grade malignant neoplasm, metastatic malignant neoplasm in the brain | Sameek Roychowdhury | Withdrawn | No outcome recorded |
| Phase 2 | NCT03535740 | Jan 2019 → Sep 2020 | — | Ariad Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03719898 | Dec 2018 → Mar 2020 | ALK-positive anaplastic large cell lymphoma | Fox Chase Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03410108 | Jan 2018 → Sep 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT02706626 | Mar 2017 → Oct 2020 | non-small cell lung carcinoma | Criterium, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02094573 | Jun 2014 → Feb 2016 | non-small cell lung carcinoma | Ariad Pharmaceuticals | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03596866 | Apr 2019 → Feb 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02737501 | May 2016 → Jul 2020 | non-small cell lung carcinoma | Ariad Pharmaceuticals | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06620835 Background | Jun 2025 → Oct 2030 expected | non-small cell lung carcinoma | Groupe Francais De Pneumo-Cancerologie | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02784158 Background | — | non-small cell lung carcinoma | Ariad Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-01-22 | Takeda | Manufacturing and Marketing Approval Received in Japan for ALUNBRIG ® in the Treatment of ALK Fusion Gene-positive Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer takeda.com ↗ |
| 2020-05-22 | Takeda | U.S. FDA Approves Takeda’s ALUNBRIG ® (brigatinib) as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer takeda.com ↗ |
| 2020-04-06 | Takeda | European Commission Approves Takeda’s ALUNBRIG ® (brigatinib) as a First-Line Treatment for ALK+ NSCLC takeda.com ↗ |
| 2020-03-02 | Takeda | Takeda Receives Positive CHMP Opinion for ALUNBRIG ® (brigatinib) as a First-Line Treatment for ALK+ Non-Small Cell Lung Cancer takeda.com ↗ |
| 2020-02-24 | Takeda | Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG ® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer takeda.com ↗ |
| 2019-11-23 | Takeda | Takeda Presents Long-Term Data in ALK+ NSCLC Showing ALUNBRIG ® (brigatinib) Continues to Demonstrate Superiority in the First-Line After Two Years of Follow-Up takeda.com ↗ |
| 2019-06-03 | Takeda | Takeda Presents Results from Lung Portfolio Including Phase 1/2 Study of TAK-788 in a Rare Form of NSCLC and New Data on Overall Health-Related Quality of Life for ALUNBRIG ® (brigatinib) takeda.com ↗ |
| 2018-11-27 | Takeda | European Commission Approves ALUNBRIG ® (brigatinib) for ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib, Advancing Treatment Paradigm in Europe takeda.com ↗ |
| 2018-10-19 | Takeda | Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG ® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer takeda.com ↗ |
| 2018-09-25 | Takeda | Takeda to Present Positive Data from ALUNBRIG ® (brigatinib) ALTA-1L Trial Showing a Reduction in Risk of Disease Progression or Death of More Than 50 Percent Versus Crizotinib in First-Line Advanced ALK+ NSCLC takeda.com ↗ |
| 2018-09-21 | Takeda | Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG ® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib takeda.com ↗ |
| 2018-07-25 | Takeda | Takeda Announces Phase 3 Trial of ALUNBRIG ® (brigatinib) Met Primary Endpoint Demonstrating Superiority in Progression-Free Survival Versus Crizotinib in Patients with ALK+ Advanced NSCLC Who are ALK Inhibitor Naïve takeda.com ↗ |
| 2017-10-16 | Takeda | Takeda Presents Updated Results from Pivotal Phase 2 ALTA Trial of ALUNBRIG TM (brigatinib) in ALK-Positive Non-Small Cell Lung Cancer takeda.com ↗ |
| 2017-09-27 | Takeda | Takeda to Feature ALUNBRIG TM (brigatinib) Data from Pivotal Phase 2 ALTA Trial at 18 th World Conference on Lung Cancer takeda.com ↗ |
| 2017-04-28 | Takeda | Takeda Announces FDA Accelerated Approval of ALUNBRIG TM (brigatinib) takeda.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brigatinib | “The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered...” NCT06620835 ↗30“Brigatinib, 90mg po qd for one week and than 180mg po qd forever” NCT05014464 ↗ |
| Known as | ALUNBRIG | “The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered...” NCT06620835 ↗ |
| Known as | AP26113 | “A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer” NCT02737501 ↗ |
| Known as | AP261136 | “The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer” NCT02706626 ↗ |
| Known as | BRIGATINIB (AP-26113) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545311 ↗ |
| Known as | BRIGATINIBAP-26113AP26113CS-4278 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545311 ↗ |
| Action | Inhibit | “Brigatinib (AP26113) is an investigational ALK inhibitor” PMID 27836716 ↗ Nov 2016 |
| Modality | Small molecule | — CHEMBL3545311 ↗ |
| Route | Oral | “orally administered brigatinib” NCT01449461 ↗ |
| Target | ALK | “Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)” NCT01449461 ↗ |
| Target | EGFR | “Oral Anaplastic Lymphoma Kinase (ALK)/Epidermal Growth Factor Receptor (EGFR) Inhibitor Brigatinib (AP26113)” NCT01449461 ↗ |