Karyopharm Gets FDA OK of Xpovio in Multiple Myeloma

tlexander
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Selinexor is a first-in-class selective inhibitor of nuclear transport (SINE) compound. It is currently approved for the treatment of multiple myeloma, a cancer which forms from antibody-producing plasma cells.6,7 This condition is typically treated with high dose bortezomib and dexamethasone
chemotherapy followed by autologous stem-cell transplant. Other
chemotherapies for multiple myeloma include lenalidomide and dexamethasone, thalidomide, and may include melphalan if the patient is not eligible for
transplant.8 Selinexor was approved by the FDA in June 2019. It was granted fast track and orphan designation as well as accelerated approval based on
single arm, open label trial data. The Bortezomib, Selinexor, and
Dexamethasone in Patients With Multiple Myeloma (BOSTON) trial is planned to finish in 2020.9

tlexander

关于XPOVIO® (selinexor, ATG-010)

XPOVIO®(selinexor,ATG-010)是全球首款且唯一一款口服型SINE化合物,由
Karyopharm开发。德琪医药与Karyopharm达成独家合作和授权,获得了包括XPOVIO&#
174;在内的四款产品在亚太地区的独家开发和商业化授权。XPOVIO®是同类首款且同类唯一一款口服型选择性核输出抑制剂(SINE)化合物,由德琪医药与Karyopharm合作研发。2019年7月,美国食品药品监督管理局(FDA)批准XPOVIO®联合低剂量地塞米松用于治疗复发难治性多发性骨髓瘤(rrMM)患者。2020年6月,美国FDA再次批准XPOVIO®作为单药口服疗法用于治疗复发难治性弥漫性大B细胞淋巴瘤(rrDLBCL)患者。此外,XPOVIO®的一项上市许可申请(MAA)已经递交欧洲药品管理局(EMA),要求有条件地批准XPOVIO®用于同一rrMM适应症。12月18日,美国FDA批准了
XPOVIO®扩展适应症的补充新药申请(sNDA),用于治疗既往接受过至少一线治疗的多发性骨髓瘤患者。XPOVIO®是目前首款且唯一一款被美国FDA批准的口服SINE
化合物。此外,XPOVIO®针对多个实体肿瘤适应症开展了多项中期和后期临床试验,包括脂肪肉瘤和子宫内膜癌。2020年11月,德琪医药合作伙伴Karyopharm在2020年结缔组织肿瘤学年会(CTOS 2020)上报告了3期SEAL研究的积极数据。SEAL研究是一项随机、双盲、安慰剂对照交叉研究,旨在比较口服单药XPOVIO®与安慰剂在脂肪肉瘤患者中的疗效。另外,Karyopharm近期公布了XPOVIO®用于治疗子宫内膜癌患者的3期SIENDO研究已完成计划的中期无效性分析,数据安全监查委员会(DSMB)推荐
SIENDO研究无需作任何修改按计划继续进行。SIENDO试验的首要数据结果预计在2021年下半年公布。

【 在 tlexander (talent) 的大作中提到: 】
: Selinexor is a first-in-class selective inhibitor of nuclear transport (
SINE
: ) compound. It is currently approved for the treatment of multiple myeloma,
: a cancer which forms from antibody-producing plasma cells.6,7 This
condition
: is typically treated with high dose bortezomib and dexamethasone
: chemotherapy followed by autologous stem-cell transplant. Other
: chemotherapies for multiple myeloma include lenalidomide and dexamethasone,
: thalidomide, and may include melphalan if the patient is not eligible for : transplant.8 Selinexor was approved by the FDA in June 2019. It was
granted
: fast track and orphan designation as well as accelerated approval based on
: single arm, open label trial data. The Bortezomib, Selinexor, and
: ...................