强生宣布兆珂速全新四药联合方案在华获批，为新诊断多发性骨髓瘤患者带来获益

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强生公司今日宣布，旗下创新治疗药物兆珂速——达雷妥尤单抗注射液（皮下注射）正式获得国家药品监督管理局批准拓展适应症，与硼替佐米、来那度胺和地塞米松联合用药治疗适合自体干细胞移植的新诊断多发性骨髓瘤成年患者。这意味着患者在新诊断阶段即有机会接受基于达雷妥尤单抗皮下注射制剂的四药联合方案，获得一项显著改善预后的全新治疗选择。　　此次获批是基于Ⅲ期PERSEUS研究结果。该研究在适合自体干细胞移植的新...

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INC"},"translate_title":"Johnson & Johnson announced that Zhaokesu's new four-drug combination regimen has been approved in China, benefiting patients with newly diagnosed multiple myeloma","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"JNJ":1.5},"content_text":"强生公司今日宣布，旗下创新治疗药物兆珂速——达雷妥尤单抗注射液（皮下注射）正式获得国家药品监督管理局批准拓展适应症，与硼替佐米、来那度胺和地塞米松联合用药治疗适合自体干细胞移植的新诊断多发性骨髓瘤成年患者。这意味着患者在新诊断阶段即有机会接受基于达雷妥尤单抗皮下注射制剂的四药联合方案，获得一项显著改善预后的全新治疗选择。　　此次获批是基于Ⅲ期PERSEUS研究结果。该研究在适合自体干细胞移植的新诊断多发性骨髓瘤患者中，对比评估了以下两种治疗方案：以达雷妥尤单抗皮下注射制剂为基础的四药联合方案（DVRd）用于诱导及巩固治疗、随后采用达雷妥尤单抗皮下注射制剂联合来那度胺进行维持治疗；采用硼替佐米、来那度胺及地塞米松（VRd）进行诱导和巩固治疗、随后以来那度胺进行维持治疗。　　中位随访47.5个月的研究数据显示，主要终点无进展生存期（PFS）获得显著改善。与VRd方案相比，DVRd方案将疾病进展或死亡风险降低了58%。在缓解深度方面，DVRd方案同样展现出显著优势：获得整体微小残留病（MRD）阴性率（检测灵敏度10）达75.2%，高于VRd组的47.5%（p < 0.0001）；达到完全缓解及以上的患者占87.9%，高于VRd组的70.1%（p < 0.0001）；尤为重要的是，获得MRD阴性持续≥12个月的患者比例达64.8%，显著高于VRd组的29.7%。　　JNJ\" target=\"_blank\" web=\"1\">强生创新制药中国区总裁黄琛表示：“此次获批的治疗方案给新诊断多发性骨髓瘤患者带来了显著的临床获益，再次印证了我们将变革性方案带给更多一线治疗患者的决心，同时我们也希望借助以达雷妥尤单抗皮下注射制剂为基础的全新治疗方案，持续推动改善治疗结局，建立新的治疗标准。在强生，我们始终致力于让多发性骨髓瘤患者实现功能性治愈，今天取得的重要进展正是朝着这一目标迈出的关键一步。我们承诺将持续构建端到端的患者健康管理体系——从早期筛查、创新治疗到长程管理，守护患者全周期健康，让创新成果不仅治疗疾病，更治愈身心。”　　多发性骨髓瘤患者临床表现差异巨大，一线治疗是患者获得最深度缓解和更长生存的关键阶段，亟需能够显著延缓疾病进展的创新疗法。凭借有力的证据，以达雷妥尤单抗皮下注射制剂为基础的四药联合方案为临床提供了一项具有变革意义的全新选择，在适合自体干细胞移植治疗的患者中展现出提高缓解深度、延长缓解持续时间的潜力。　　DVRd方案的整体安全性与达雷妥尤单抗皮下注射制剂及VRd方案的已知安全性特征一致。最常见的血液学不良反应（发生率≥20%）包括中性粒细胞减少症、血小板减少症和贫血。最常见的非血液学不良反应包括周围神经病变、疲乏、外周水肿、发热、上呼吸道感染、新型冠状病毒感染、便秘、腹泻、背痛、失眠、乏力和皮疹。（文章来源：上观新闻）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 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