强生公司寻求在欧洲扩大伊布替尼的适应症

2018-11-15 MedSci MedSci原创

强生公司近日宣布,已向欧洲药品管理局(EMA)提交了两份申请,以寻求扩大伊布替尼的适应症。第一项申请旨在申请在先前未治疗的成人慢性淋巴细胞白血病(CLL)中使用伊布替尼与obinutuzumab的组合,第二项申请旨在申请在先前未治疗和复发/难治的华氏巨球蛋白血症(WM)中使用伊布替尼与利妥昔单抗的组合。

强生公司近日宣布,已向欧洲药品管理局(EMA)提交了两份申请,以寻求扩大伊布替尼的适应症。第一项申请旨在申请在先前未治疗的成人慢性淋巴细胞白血病CLL)中使用伊布替尼与obinutuzumab的组合,第二项申请旨在申请在先前未治疗和复发/难治的华氏巨球蛋白血症(WM)中使用伊布替尼与利妥昔单抗的组合。强生公司中东和非洲(EMEA血液学治疗区负责人Catherine Taylor博士说:对于患有血癌的患者而言,伊布替尼持续显示出长期临床益处,我们期待与相关机构合作以确保批准这些新组合

伊布替尼是一种非可逆性的Bruton酪氨酸激酶(BTK)抑制剂,由强生公司和AbbVie公司共同开发和商业化。在先前未治疗的CLL患者中使用伊布替尼的申请得到了PCYC-1130研究的积极结果的支持,该研究调查了利妥昔单抗与苯丁酸氮芥和obinutuzumab与伊布替尼用于初治CLL患者的有效性和安全性。同时对RESONATETMRESONATETM-2研究的进一步分析结果与现实世界的证据数据库进行比较发现,伊布替尼在初治和复发难治CLL/MCL/WM中具有显著有效性。


原始出处:

http://www.firstwordpharma.com/node/1604631#axzz5WvWo4v35

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