濾泡性淋巴瘤是常見的惡性血液病，有較高的發(fā)病率，與磷脂酰肌醇-3-激酶（PI3K）信號通路的失調(diào)相關(guān)。Copanlisib是拜耳公司研制的抗濾泡性淋巴瘤的孤兒藥，也是全球首個(gè)泛I類磷脂酰肌醇-3-激酶高效選擇性抑制劑，對復(fù)發(fā)性或難治性濾泡性淋巴瘤成人患者有良好的療效。它的有效性和安全性已被臨床試驗(yàn)充分證實(shí)，于2017年9月獲得美國FDA的批準(zhǔn)在臨床使用。概述了Copanlisib的藥效學(xué)、藥動(dòng)學(xué)、臨床試驗(yàn)和安全性等研究情況。

Follicular lymphoma is a common malignant hematonosis with comparatively high morbidity, which is linked closely with dysregulated phosphatidylinositol 3-kinases (PI3Ks) signal pathway. Copanlisib developed by Bayer Group is an orphan drug treating follicular lymphoma as well as the world's first pan-class I PI3Ks inhibitor featuring the high selectivity. It demonstrated a potent activity for the treatment of adult patients with relapsed follicular lymphoma. Clinical trials have demonstrated its efficacy and safety, and the U.S. Food and Drug Administration (FDA) officially approved its clinical application in September 2017. In the article, authors mainly described its pharmacodynamics, pharmacokinetics, clinical trials, and safety.