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Ref Type
PMID
Authors
Title Calquence (acalabrutinib) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210259
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
Drug Name Trade Name Synonyms Drug Classes Drug Description
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
Unknown unknown chronic lymphocytic leukemia not applicable Acalabrutinib FDA approved Actionable In a Phase III trial (ELEVATE TN) that supported FDA approval, Calquence (acalabrutinib) treatment resulted in prolonged progression-free survival compared to Gazyva (obinutuzumab) plus chlorambucil (HR=0.20, p<0.0001) in patients with treatment-naive chronic lymphocytic leukemia (PMID: 31724010; NCT02475681). 31724010 detail...
Unknown unknown mantle cell lymphoma not applicable Acalabrutinib Phase II Actionable In a Phase II trial (ACE-LY-004) that supported FDA approval, Calquence (acalabrutinib) treatment resulted in an overall response rate of 81% (100/124, 49 complete response) in patients with relapsed or refractory mantle cell lymphoma (PMID: 29241979; NCT02213926). 29241979 detail...