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Published in: Drugs 18/2017

01-12-2017 | AdisInsight Report

Copanlisib: First Global Approval

Author: Anthony Markham

Published in: Drugs | Issue 18/2017

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Abstract

Bayer are developing copanlisib (Aliqopa™)—a pan-class I phosphoinositide 3-kinase (PI3K) inhibitor—as a treatment for various haematological and solid malignancies. The US FDA has granted copanlisib accelerated approval for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies based on the results of a phase II trial. Phase III trials are underway evaluating copanlisib as treatment for relapsed/refractory diffuse large B-cell lymphoma and in combination with rituximab or rituximab-based chemotherapy or standard immunochemotherapy in patients with relapsed indolent B-cell non-Hodgkin’s lymphoma. Phase I/II studies are underway in relapsed or refractory peripheral T-cell or NK/T-cell lymphoma, advanced cholangiocarcinoma, hormone receptor-positive HER2-negative stage I-IV breast cancer, HER2-positive breast cancer and recurrent and/or metastatic head and neck squamous cell carcinomas harbouring a PI3KCA mutation/amplification and/or a PTEN loss. This article summarizes the milestones in the development of copanlisib leading to this first approval for relapsed follicular lymphoma.
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Metadata
Title
Copanlisib: First Global Approval
Author
Anthony Markham
Publication date
01-12-2017
Publisher
Springer International Publishing
Published in
Drugs / Issue 18/2017
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-017-0838-6

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