智通财经APP获悉，强生(JNJ.US)日前宣布，欧洲药品管理局(EMA)人用药品委员会(CHMP)已推荐扩展Darzalex(daratumumab)皮下注射(SC)剂型的适应症，使用皮下注射Darzalex联合硼替佐米、来那度胺和地塞米松(D-VRd)，一线治疗新确诊的多发性骨髓瘤成年患者。
CHMP的推荐基于3期临床试验CEPHEUS的数据，该研究评估了D-VRd与硼替佐米、来那度胺和地塞米松(VRd)相比，在不适合接受移植或不计划将自体干细胞移植(ASCT)作为初始治疗的患者中的疗效和安全性。该研究数据此前已在2024年国际骨髓瘤学会(IMS)年会及2024年美国血液学会(ASH)年会上展示。
Darzalex皮下注射剂型由强生和Genmab联合开发，是首款可以通过皮下注射给药的抗CD38抗体，将患者接受治疗的时间从几个小时缩短到几分钟。它已经获得批准用于多发性骨髓瘤的8个适应症，其中4个适应症用于一线治疗。
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