Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 30 mg, 90 mg, 180 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Latest News
Summary
- Alunbrig (brigatinib) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
- This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
- Brigatinib showed significant improvement in overall PFS compared to crizotinib (HR: 0.48, 95% CI: 0.35 to 0.66) and ceritinib (HR: 0.38, 95% CI: 0.23 to 0.60) in first-line treatment settings and was comparable to other second-generation ALK inhibitors.
- Brigatinib demonstrated robust intracranial PFS, with an iPFS of 19.26 months in patients with baseline brain metastases, indicating strong efficacy in treating brain metastases.
- The overall survival benefit of brigatinib was observed in comparison to crizotinib (HR: 0.50, 95% CI: 0.28 to 0.87), but it showed no significant difference in OS when compared to other next-generation ALK inhibitors.
- Brigatinib had a pooled ORR of 64% (95% CI 45%-83%) and a DCR of 88% (95% CI 80%-96%), demonstrating superior ORR to crizotinib and being comparable to other next-generation ALK inhibitors.
- Brigatinib had a higher rate of grade 3-4 adverse events (63.7%) compared to alectinib (16.2%) but lower than lorlatinib (91.6%) and similar to ensartinib and ceritinib.
- The most frequent adverse events associated with brigatinib included gastrointestinal reactions, hypertension, cough, headache, elevated ALT/AST levels, and increased creatine phosphokinase (CPK).
- Brigatinib's incidence of serious adverse events was comparable to other next-generation ALK inhibitors except for alectinib, which had a notably lower rate.
- Brigatinib was particularly effective in patients with baseline brain metastases, showing significant intracranial progression-free survival (iPFS), and demonstrated comparable efficacy in Asian populations, although ensartinib sometimes showed superior efficacy in this subgroup.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Alunbrig (Brigatinib) Prescribing Information. | 2022 | Takeda Pharmaceutical Company Limited, Cambridge, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| BC Cancer protocol summary for first-line treatment of ALK-positive advanced non-small cell lung cancer (NSCLC) with Brigatinib. | 2022 | BC Cancer |
| Guidelines for clinical practice of ALK fusion detection in non-small-cell lung cancer: a proposal from the Chinese RATICAL study group. | 2021 | Journal of the National Cancer Center |
| Therapy for stage IV non–small-cell lung cancer with driver alterations: ASCO and OH (CCO) joint guideline update. | 2021 | Journal of Clinical Oncology |
| Metastatic non-small cell lung cancer: ESMO. | 2019 | Annals of Oncology |
| Pan-Canadian oncology drug review final clinical guidance report brigatinib (alunbrig) for non-small cell lung cancer. | 2019 | Canadian Agency for Drugs and Technologies in Health |