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Alunbrig (brigatinib)
Alunbrig works by blocking the activity of the ALK tyrosine kinase receptor, which is involved in the growth and spread of cancer cells.
At a glance
| Generic name | brigatinib |
|---|---|
| Sponsor | Takeda |
| Drug class | Kinase Inhibitor [EPC] |
| Target | ALK tyrosine kinase receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
Brigatinib is tyrosine kinase inhibitor with in vitro activity at clinically achievable concentrations against multiple kinases including ALK, ROS1, insulin-like growth factor-1 receptor (IGF-1R), and FLT-3 as well as EGFR deletion and point mutations. Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signaling proteins STAT3, AKT, ERK1/2, and S6 in in vitro and in vivo assays. Brigatinib also inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice.At clinically achievable concentrations (<=500 nM), brigatinib inhibited the in vitro viability of cells expressing EML4-ALK and 17 mutant forms associated with resistance to ALK inhibitors including crizotinib, as well as EGFR-Del (E746-A750), ROS1-L2026M, FLT3-F691L, and FLT3-D835Y. Brigatinib exhibited in vivo antitumor activity
Approved indications
- Advanced/recurrent anaplasticlymphoma kinase (ALK)-positive non-small cell lung cancer
- Non-small cell lung cancer
Common side effects
- ILD/Pneumonitis
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Rash
- Cough
- Dyspnea
- Fatigue
- Hypertension
- Pyrexia
- Myalgia
Key clinical trials
- Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (PHASE2)
- Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer
- Advancing Brigatinib Properties in ALK+ NSCLC Patients by Deep Phenotyping (PHASE2)
- A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
- Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (PHASE2)
- Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2) (PHASE2)
- A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
- Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors (PHASE1,PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Alunbrig CI brief — competitive landscape report
- Alunbrig updates RSS · CI watch RSS
- Takeda portfolio CI