FDA批准Monjuvi用于复发性、难治性滤泡性淋巴瘤

亿欧网06-24

美国食品药品监督管理局（FDA）已批准Monjuvi（tafasitamab-cxix），一种人源化的Fc修饰溶细胞CD19靶向单克隆抗体，用于治疗复发或难治性滤泡性淋巴瘤的成年患者。该批准基于3期临床试验inMIND的结果，该试验显示，与安慰剂组相比，Monjuvi组在无进展生存期（PFS）方面取得了具有统计学意义和临床意义的显著改善。然而，在接受Monjuvi联合利妥昔单抗和来那度胺治疗的患者...

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