Copanlisib
Clinical data | |
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Trade names | Aliqopa |
Other names | BAY 80-6946 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a617044 |
License data |
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Intravenous | |
Drug class | PI3-Kinase inhibitor |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Protein binding | 84.2%[1] |
Metabolism | CYP3A4/5 (≈90%), CYP1A1 (≈10%)[1] |
Elimination half-life | 39.1 hours (range: 14.6 to 82.4)[1] |
Excretion | Feces (64%), Urine (22%); 14% were not recovered[1] |
Identifiers | |
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JSmol) | |
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Copanlisib, sold under the brand name Aliqopa,[1] is a medication used for the treatment of adults experiencing relapsed follicular lymphoma who have received at least two prior systemic therapies.[1][2]
Adverse effects
Data for safety and efficacy of copanlisib are described in the consumer-targeted FDA Drug Trial Snapshot.
Mechanism of action
Copanlisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B-cells. It has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines.[1]
History
Efficacy resulting in the approval of copanlisib was based on the subgroup of 104 patients with follicular lymphoma from a Phase 2 clinical trial.[4] Of these, 59 percent had a complete or partial shrinkage of their tumors that lasted about 12 months.
To assess the safety of the drug, data from 168 adults with follicular lymphoma and other hematologic malignancies treated with copanlisib were evaluated.[3]
Clinical trials
Phase II clinical trials are in progress for treatment of
In a preclinical study, copanlisib was effective in inhibiting
Society and culture
Legal status
For follicular lymphoma, the U.S.
In September 2017, it received
Copanlisib was granted orphan drug status for the treatment of splenic, nodal and extranodal subtypes of marginal zone lymphoma.[14]
References
- ^ a b c d e f g h "Aliqopa- copanlisib injection, powder, lyophilized, for solution". DailyMed. 23 February 2022. Retrieved 1 April 2023.
- ^ "FDA approves new treatment for adults with relapsed follicular lymphoma" (Press release). U.S. Food and Drug Administration (FDA). 24 March 2020. Retrieved 1 April 2023.
- ^ a b "Drug Trials Snapshots Aliqopa". U.S. Food and Drug Administration (FDA). 30 June 2020.
- ^ a b Clinical trial number NCT01660451 for "Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas" at ClinicalTrials.gov
- ^ Clinical trial number NCT02728258 for "Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer" at ClinicalTrials.gov
- ^ Clinical trial number NCT02391116 for "Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)" at ClinicalTrials.gov
- ^ Clinical trial number NCT02631590 for "Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma" at ClinicalTrials.gov
- ^ Clinical trial number NCT02626455 for "Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)" at ClinicalTrials.gov
- ^ Clinical trial number NCT02367040 for "Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)" at ClinicalTrials.gov
- ^ Clinical trial number NCT02369016 for "Phase III Copanlisib in Rituximab-refractory iNHL" at ClinicalTrials.gov
- S2CID 25568678.
- ^ Clinical trial number NCT02705859 for "Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study)" at ClinicalTrials.gov
- ^ "NDA 209936, Multisciplinary Review document, chapter 3" (PDF). U.S. Food and Drug Administration (FDA).
- ^ a b "Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies" (Press release). Bayer AG. 14 September 2017.
- ^ "NDA 209936, Approval Letter" (PDF). U.S. Food and Drug Administration (FDA).
External links
- "copanlisib hydrochloride". NCI Drug Dictionary.