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[摘要]
滤泡性淋巴瘤是常见的恶性血液病,有较高的发病率,与磷脂酰肌醇-3-激酶(PI3K)信号通路的失调相关。Copanlisib是拜耳公司研制的抗滤泡性淋巴瘤的孤儿药,也是全球首个泛I类磷脂酰肌醇-3-激酶高效选择性抑制剂,对复发性或难治性滤泡性淋巴瘤成人患者有良好的疗效。它的有效性和安全性已被临床试验充分证实,于2017年9月获得美国FDA的批准在临床使用。概述了Copanlisib的药效学、药动学、临床试验和安全性等研究情况。
[Key word]
[Abstract]
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.
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