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Ref Type
PMID
Authors
Title Alunbrig (brigatinib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208772
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Brigatinib Brigatinib 181 21
Drug Name Trade Name Synonyms Drug Classes Drug Description
Brigatinib Alunbrig AP26113 ALK Inhibitor 33 EGFR Inhibitor (Pan) 63 FLT3 Inhibitor 69 IGF-1R Inhibitor 17 ROS1 Inhibitor 23 Alunbrig (brigatinib) is a multi-kinase inhibitor with selected activity against ALK, ROS1 fusions, FLT3, IGF1R and mutant EGFR, potentially resulting in decreased tumor growth (PMID: 27780853). Alunbrig (brigatinib) is FDA approved for use in patients with ALK-positive metastatic non-small cell lung cancer (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (ALTA) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in an overall response rate of 45% (51/112) in the 90mg arm and 54% (59/110) in the 180mg arm, and median progression-free survival of 9.2 and 11.0 months respectively, in ALK-rearranged (fusion) non-small cell lung carcinoma patients who progressed on Xalkori (crizotinib) (PMID: 28475456; NCT02094573). detail... 28475456
ALK fusion lung non-small cell carcinoma sensitive Brigatinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (ALTA) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in an overall response rate of 45% (51/112) in the 90mg arm and 54% (59/110) in the 180mg arm, and median progression-free survival of 9.2 and 11.0 months respectively, in ALK-rearranged (fusion) non-small cell lung carcinoma patients who progressed on Xalkori (crizotinib) (PMID: 28475456; NCT02094573). 28475456 detail...
ALK rearrange lung non-small cell carcinoma sensitive Brigatinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in a superior estimated 12-month progression-free survival rate (67% vs 43%, HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in ALK inhibitor-naive patients with ALK-rearrangement positive metastatic non-small cell lung cancer, with a confirmed objective response rate of 71% vs 60%, and confirmed intracranial response rate of 78% vs 29% (PMID: 30280657; NCT02737501). detail... detail... 30280657
ALK fusion lung non-small cell carcinoma sensitive Brigatinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in a superior estimated 12-month progression-free survival rate (67% vs 43%, HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in ALK inhibitor-naive patients with ALK-rearrangement positive metastatic non-small cell lung cancer, with a confirmed objective response rate of 71% vs 60%, and confirmed intracranial response rate of 78% vs 29% (PMID: 30280657; NCT02737501). detail... 30280657 detail...