Copanlisib

Overview

Copanlisib is a selective pan-Class I phosphoinositide 3-kinase (PI3K) inhibitor with preferential activity against the alpha and delta isoforms. PI3K, a lipid kinase that activates downstream signalling pathways involved in cell survival and growth, that exists in different isoforms and is often overexpressed in hematological malignancies. Copanlisib was granted accelerated approval by the FDA in September 2017 for the treatment of follicular lymphoma.

Background

Indication

Copanlisib is indicated for the treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. This indication was granted under accelerated approval; thus, continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Associated Conditions

Relapsed Follicular Lymphoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)	2024/05/06	NCT06400238	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G)	2024/04/11	NCT06360588	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors	2024/02/02	NCT06238583	N/A	NO_LONGER_AVAILABLE	Bayer
A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer	2024/01/23	NCT06218667	Phase 1	Withdrawn	Memorial Sloan Kettering Cancer Center
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer	2023/01/18	NCT05687721	Phase 1	Withdrawn	VA Office of Research and Development
Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)	2022/08/08	NCT05490771	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden	2022/05/24	NCT05387616	Phase 2	Active, not recruiting	Ludwig-Maximilians - University of Munich
Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy	2022/03/25	NCT05295589	Phase 2	Withdrawn	National Cancer Institute (NCI)
A Study to Learn More About Copanlisib Treatment Patterns in People With Indolent Non-Hodgkin Lymphoma, a Type of Cancer That Grows and Spread Slowly and Develops in the Lymphatic System (a Part of Immune System) in Taiwan Under Real-word Conditions	2022/02/01	NCT05217914	N/A	Completed	Bayer
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations	2021/10/18	NCT05082025	Phase 2	Active, not recruiting	M.D. Anderson Cancer Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ALIQOPA	Bayer HealthCare Pharmaceuticals Inc.	50419-385	INTRAVENOUS	15 mg in 1 mL	9/14/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Copanlisib Hydrochloride for Injection	BAYER HEALTHCARE PHARMACEUTICALS INC.	国药准字HJ20230056	化学药品	注射剂	5/19/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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