Zou Limin, Qi Yueli, Tang Ling, Du Yu, Xiang Meiyi, Chen Xiaoming, Ma Jun, Yang Zhimin
Office of Clinical Evaluation 1, Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
Office of Management and Communication, Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
Chin J Cancer Res. 2022 Aug 30;34(4):415-421. doi: 10.21147/j.issn.1000-9604.2022.04.09.
Several phosphoinositide 3-kinase (PI3K) inhibitors are currently approved to treat hematolymphatic malignant diseases worldwide, and many drugs that have the same target are in the clinical research stage. In March 2022, duvelisib became the first PI3K inhibitor approved in China indicated for the treatment of hematolymphatic malignant diseases. Meanwhile, linperlisib and copanlisib have almost completed the technical review of the clinical specialty. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) found that class I PI3K inhibitors can cause various degrees of immune-related adverse events, which are associated with action mechanisms, affecting the benefit-risk assessment of the drugs. On April 21, 2021, the United States Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the safety of PI3K inhibitors indicated for hematolymphatic malignancies and their related risk of death. The hematological tumor group of CDE of the China NMPA summarized and combined the data on PI3K inhibitors listed or under technical review for marketing authorization applications and found that such products may have unique efficacy and safety characteristics in Chinese patients with malignant lymphoma.
目前，全球有几种磷酸肌醇3-激酶（PI3K）抑制剂已获批用于治疗血液淋巴系统恶性疾病，许多具有相同靶点的药物正处于临床研究阶段。2022年3月，度维利塞成为中国首个获批用于治疗血液淋巴系统恶性疾病的PI3K抑制剂。同时，林普利塞和库潘尼西已基本完成临床专业的技术审评。国家药品监督管理局药品审评中心（CDE）发现，I类PI3K抑制剂可引发不同程度的免疫相关不良事件，这与作用机制有关，影响药物的获益-风险评估。2021年4月21日，美国食品药品监督管理局（FDA）召开肿瘤药物咨询委员会（ODAC）会议，讨论用于血液淋巴系统恶性肿瘤的PI3K抑制剂的安全性及其相关死亡风险。国家药监局药品审评中心血液肿瘤组汇总并整合了已上市或正在进行上市许可申请技术审评的PI3K抑制剂的数据，发现此类产品在中国恶性淋巴瘤患者中可能具有独特的疗效和安全性特征。
