Drug updated on 10/30/2024
| 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
- This summary is based on the review of 23 systematic review(s)/meta-analysis(es). [1-23]
- Brigatinib significantly improved Progression-Free Survival (PFS) compared to crizotinib (Hazard Ratio (HR): 0.48, 95% Confidence Interval (CI): 0.35 to 0.66) and showed varying PFS across treatment lines, including 24.00 months in first-line, 16.26 months post-crizotinib, and 12.96 months after any prior Anaplastic Lymphoma Kinase (ALK)-Tyrosine Kinase Inhibitor (TKI).
- Brigatinib had a pooled Objective Response Rate (ORR) of 64% (95% CI: 45%-83%), with no significant differences in ORR when compared to alectinib and lorlatinib.
- Brigatinib demonstrated robust intracranial efficacy, with an intracranial PFS of 19.26 months in patients with brain metastases and the lowest Number Needed to Treat (NNT) for intracranial outcomes alongside lorlatinib.
- No significant differences in Overall Survival (OS) were observed between brigatinib and other next-generation ALK inhibitors.
- Brigatinib had higher rates of grade 3-4 adverse events (63.7%) compared to alectinib (16.2%) but lower compared to lorlatinib (91.6%). Common adverse events included increased Creatine Phosphokinase (CPK) (44%), diarrhea (37%), and nausea (28%).
- Brigatinib was associated with a lower risk of total thromboembolism (Odds Ratio (OR): 0.31; 95% CrI: 0.11 to 0.79) and venous thromboembolism (OR: 0.18; 95% CrI: 0.04 to 0.6) compared to crizotinib.
- Brigatinib had the highest incidence of all-grade pneumonitis (7.09%) and high-grade pneumonitis (3.06%) among ALK TKIs.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Alunbrig (brigatinib) Prescribing Information. | 2022 | Takeda Pharmaceuticals U.S.A., Inc., Lexington, 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 |