copanlisib (Discontinued)

Brand and Other Names:Aliqopa (DSC)

Dosing & Uses

Follicular Lymphoma

In November 2023, copanlisib was voluntarily withdrawn for follicular lymphoma

The decision was based on recently updated CHRONOS-4 study that showed the addition of copanlisib to standard immunochemotherapy regimens did not improve progression-free survival

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Pharmacology

Mechanism of Action

Pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells; by inhibiting several key cell-signaling pathways may induce apoptosis and inhibition of proliferation of premalignant B cells and in turn cause tumor cell death

Absorption

Peak plasma concentration: 463 ng/mL

AUC (0-25): 1570 ng·hr/mL

Distribution

Protein binding: 84.2% (mainly albumin)

Vd: 871 L

Metabolism

Metabolism is mediated by CYP3A (~90%) and CYP1A1 (<10%)

Elimination

Half-life: 39.1 hr Clearance: 17.9 L/hr

Excreted ~50% as unchanged compound and 50% as metabolites

Excretion, unchanged compound: Feces (30%), urine (15%)

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.