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Ref Type
PMID
Authors
Title Revlimid (lenalidomide) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021880
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
Lenalidomide Revlimid IMiD-1 Revlimid (lenalidomide) is a thalidomide analog which regulates cytokine production and stimulates T cells and NK cells activity (PMID: 24328678). Revlimid (lenalidomide) is FDA approved for use in multiple myeloma, relapsed or refractory Mantle cell lymphoma, and in combination with a rituximab product in follicular lymphoma and marginal zone lymphoma (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
Unknown unknown follicular lymphoma not applicable Lenalidomide + Rituximab FDA approved Actionable In a Phase III trial (AUGMENT) that supported FDA approval, Revlimid (lenalidomide) in combination with Rituxan (rituximab) resulted in significantly improved progression-free survival (39.4 vs 14.1 months, HR=0.46, p<0.001) compared to placebo and Rituxan (rituximab) in patients with relapsed and/or refractory follicular or marginal zone lymphoma (PMID: 30897038; NCT01938001). 30897038 detail...
Unknown unknown marginal zone B-cell lymphoma not applicable Lenalidomide + Rituximab FDA approved Actionable In a Phase III trial (AUGMENT) that supported FDA approval, Revlimid (lenalidomide) in combination with Rituxan (rituximab) resulted in significantly improved progression-free survival (39.4 vs 14.1 months, HR=0.46, p<0.001) compared to placebo and Rituxan (rituximab) in patients with relapsed and/or refractory follicular or marginal zone lymphoma (PMID: 30897038; NCT01938001). 30897038 detail...
Unknown unknown mantle cell lymphoma not applicable Lenalidomide FDA approved Actionable In a Phase II trial (EMERGE) that supported FDA approval, Revlimid (lenalidomide) treatment resulted in an objective response rate of 28% (37/134) with rapid time to response (2.2 months), a median duration of response of 16.6 months, a median progression-free survival of 4.0 months, and a median overall survival of 19.0 months in patients with mantle cell lymphoma who relapsed or progressed after or were refractory to Velcade (bortezomib) (PMID: 24002500; NCT00737529). 24002500 detail...