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Bayer withdraws PI3K inhibitor application for one indication

 Last Update: 2022-05-28
 Source: Internet
 Author: User

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On February 21, the State Food and Drug Administration announced the pending receipt of the drug notification, and Bayer's PI3K inhibitor copanlisib was listed

Copanlisib is an intravenously administered phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity against both PI3K-α and PI3K-δ isoforms expressed in malignant B cells, which can be inhibited by apoptosis apoptosis and inhibit the proliferation of malignant B cells to induce tumor cell death

Bayer submitted the first domestic application for the product in March 2021 for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two systemic therapies in the past.

According to the European Medicines Agency (EMA) website, Bayer withdrew a marketing application for copanlisib in the EU in December 2021 for the treatment of adult patients with previously treated marginal zone lymphoma (MZL)

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