塞利尼索在多发性骨髓瘤临床应用的专家共识(2022)

Chinese consensus recommendations for the clinical application of selinexor in multiple myeloma(2022)

塞利尼索是全球首个强效、口服的核输出蛋白抑制剂,具备独特的作用机制且影响多条信号通路,能协同增强其他药物的抗肿瘤活性。国内外多项临床研究证实以塞利尼索为基础的联合方案治疗复发难治性多发性骨髓瘤,可获得较高缓解率,更好改善患者预后。塞利尼索联合方案已被多个指南推荐用于复发难治性骨髓瘤患者。2019年美国食品药品监督管理局(FDA)批准塞利尼索用于复发难治性多发性骨髓瘤。在我国,塞利尼索于2021年12月获批上市。鉴于上市之初临床医生用药经验尚不丰富,中华医学会血液学分会浆细胞疾病学组牵头制定了塞利尼索在骨髓瘤临床应用的专家共识,旨在为中国临床医生提供用药参考。

Selinexor, as the world’s first-in-class oral drug, is a highly selective inhibitor against exportin 1. It has a unique mechanism of action and affects multiple signal pathways, which can synergistically enhance the antitumor activity of other drugs. Many studies have confirmed that the combination regimens based on selinexor in the treatment of relapsed and refractory multiple myeloma have achieved a high response rate and improved a better prognosis. In addition, selinexor has been recommended by several leading clinical guidelines for the treatment of multiple myeloma. In 2019, selinexor was approved by FDA for the treatment of patients with relapsed and refractory multiple myeloma and has received conditional approval for marketing by the China’s National Medical Products Administration(NMPA) in December 2021. In view of the lack of clinical experience at the beginning of the market in China, the Plasma Cell Disease Group of Chinese Medical Association of Hematology Society is leading to develop an expert consensus on the clinical application of selinexor in myeloma, aiming to provide a reference for Chinese physician.