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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 1 milestone | |||||
| Filed | EU (EMA) | ALUNBRIG | non-small cell lung carcinoma | — | “A Marketing Authorization Application (MAA) for ALUNBRIG was submitted to the European Medicines Agency (EMA) in February 2017.” takeda.com ↗ “A Marketing Authorization Application (MAA) for ALUNBRIG was submitted to the European Medicines Agency (EMA) in February 2017.” takeda.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 Stop: Enrollment |
| 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| Sep 2020 → Sep 2023 | ALK-positive anaplastic large cell lymphoma, inflammatory myofibroblastic tumor | Takeda | Withdrawn | No outcome recorded Stop: Business |
| 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 · 1 met primary · 1 missed | ||||||
| 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 Stop: Enrollment |
| Phase 2 | NCT05718297 | Jun → Sep 2024 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| Phase 2 | NCT03719898 | Dec 2018 → Mar 2020 | ALK-positive anaplastic large cell lymphoma | Fox Chase Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT02094573 | Jun 2014 → Feb 2016 | non-small cell lung carcinoma | Ariad Pharmaceuticals | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT03596866 | Apr 2019 → Feb 2024 | — | Takeda | Completed | Missed primary |
| Phase 3 | NCT02737501 | May 2016 → Jul 2020 | non-small cell lung carcinoma | Ariad Pharmaceuticals | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT06620835 Background | Jun 2025 → Oct 2030 expected | non-small cell lung carcinoma | Groupe Francais De Pneumo-Cancerologie | Recruiting | No outcome recorded |
| — | NCT02784158 Background | — | non-small cell lung carcinoma | Ariad Pharmaceuticals | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2022-06-03 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to be Used as Companion Diagnostic of Four Drugs for the Treatment of Non-Small Cell Lung Cancer and Malignant Melanoma chugai-pharm.co.jp ↗ |
| 2021-01-22 | Takeda | Regulatory 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 ↗
ALUNBRIG has been shown to be an effective inhibitor of ALK gene mutations, including in patients with brain metastases, and its approval in Japan is an important milestone for both newly diagnosed and refractory ALK-positive patients. |
| 2020-09-18 | Takeda | Results Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress takeda.com ↗
Key Results from Phase 3 ALTA 1L Sub-Analyses Further Support ALUNBRIG’s Strong Intracranial Efficacy and Enhanced Quality of Life in First-Line ALK+ NSCLC |
| 2020-05-22 | Takeda | Regulatory 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 ↗
This approval expands ALUNBRIG’s current indication to include the first-line setting. |
| 2020-04-06 | Takeda | Regulatory European Commission Approves Takeda’s ALUNBRIG ® (brigatinib) as a First-Line Treatment for ALK+ NSCLC takeda.com ↗ |
| 2020-03-02 | Takeda | Regulatory 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 | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s supplemental New Drug Application (sNDA) to expand the use of ALUNBRIG (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. |
| 2019-11-23 | Takeda | Results 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 ↗
ALUNBRIG also demonstrated a 57% (HR = 0.43, 95% CI: 0.31–0.61) reduction in risk of disease progression or death in all patients. |
| 2019-06-03 | Takeda | Results 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 ↗
These findings add to the collection of data featured at this year’s meeting from Takeda’s lung cancer portfolio, which also revealed key insights from sub-analyses of ALUNBRIG (brigatinib), including quality of life data from the Phase 3 ALTA-1L ( A LK in L ung Cancer T rial of Brig A tinib in 1 st L ine) trial. |
| 2018-11-27 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited ( TSE: 4502 ) today announced that the European Commission (EC) granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
| 2018-10-19 | Takeda | Results 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 ↗
In Patients with Brain Metastases at Baseline, ALUNBRIG Reduced the Risk of Progression in the Brain or Death by 73 Percent |
| 2018-09-25 | Takeda | Results 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 ↗
ALTA-1L Met its Primary Endpoint Showing Superiority in Blinded Independent Review Committee-Assessed Progression-Free Survival Compared to Crizotinib |
| 2018-09-21 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited ( TSE: 4502 ) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG ® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. |
| 2018-07-25 | Takeda | Results 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 | Results Takeda Presents Updated Results from Pivotal Phase 2 ALTA Trial of ALUNBRIG TM (brigatinib) in ALK-Positive Non-Small Cell Lung Cancer takeda.com ↗
Sixty-Seven Percent of Patients with Measurable Brain Metastases at Baseline had an Intracranial Objective Response with a Median Duration of Intracranial Response of 16.6 Months |
| 2017-04-28 | Takeda | Regulatory Takeda Announces FDA Accelerated Approval of ALUNBRIG TM (brigatinib) takeda.com ↗
This indication is approved under Accelerated Approval based on tumor response rate and duration of response. |
All press releases naming this drug 17 releases
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 ↗ |