Copanlisib: First Global Approval
Copanlisib: First Global Approval
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DOI：
10.1007/s40265-017-0838-6
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发表时间：
2017-12-01
期刊：
影响因子：
11.5
通讯作者：
Markham, Anthony
中科院分区：
文献类型：
--
作者：
Markham, Anthony
拜耳公司正在开发copanlisib（Aliqopa（TM））-一种泛I类磷酸肌醇3-激酶（PI 3 K）激动剂-作为各种血液和实体恶性肿瘤的治疗。美国FDA已批准copanlisib加速批准用于治疗患有复发性滤泡性淋巴瘤的成年人，这些人根据II期试验的结果接受了至少两种先前的全身治疗。III期试验正在进行中，评估copanlisib作为复发性/难治性弥漫性大B细胞淋巴瘤的治疗，以及与利妥昔单抗或基于利妥昔单抗的化疗或标准免疫化疗联合治疗复发性惰性B细胞非霍奇金淋巴瘤患者。I/II期研究正在复发性或难治性外周T细胞或NK/T细胞淋巴瘤、晚期胆管癌、激素受体阳性HER 2阴性I-IV期乳腺癌、HER 2阳性乳腺癌和携带PI 3 KCA突变/扩增和/或PTEN缺失的复发性和/或转移性头颈部鳞状细胞癌中进行。这篇文章总结了copanlisib开发的里程碑，导致首次批准用于复发性滤泡性淋巴瘤。
Bayer are developing copanlisib (Aliqopa (TM))-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.