Drug updated on 4/18/2024
| 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.
Summary
- Brigatinib (Alunbrig) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), providing significant efficacy in progression-free survival and overall survival, notably in the first-line setting and for patients with CNS metastases.
- The analysis is based on 14 systematic reviews/meta-analyses that compared Alunbrig's safety and effectiveness with other ALK inhibitors such as alectinib, lorlatinib, ensartinib, and ceritinib.
- Alectinib showed superior progression-free survival rates, particularly in the first-line setting and for patients with brain metastases, making it one of the most effective ALK inhibitors according to multiple studies reviewed.
- Lorlatinib demonstrated remarkable efficacy, especially among those with CNS metastases, but its higher rate of grade 3 or higher adverse events raised concerns about its safety profile.
- In terms of safety profiles among all compared drugs, alectinib had the lowest rates of serious adverse events, while brigatinib had moderate incidence levels; however, lorlatinib posed the greatest risk due to a high occurrence rate of severe side effects.
- For the Asian patient subgroup specifically, both alectinib and ensartinib significantly improved PFS outcomes, indicating their particular effectiveness within this population group.
- Patients presenting baseline CNS metastasis responded best to lorlatinib and brigatinib, suggesting these two are strong candidates when treating this specific patient subgroup.
- The adverse event spectrum varied widely across different drugs: brigatinib commonly caused gastrointestinal reactions along with hypertension and elevated liver enzymes, whereas unique side effects associated only with lorlatinib included significant changes in lipid levels alongside weight gain, cognitive effects, mood alterations, etc.
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 |