强生旗下创新治疗药物泽倍珂新适应症获批

中金财经
Jun 24

  强生公司近日宣布,旗下创新治疗药物泽倍珂?(尼拉帕利阿比特龙片)正式获得国家药品监督管理局批准,联合泼尼松或泼尼松龙用于携带胚系和/或体系BRCA2基因突变的转移性内分泌治疗敏感性前列腺癌成人患者(mHSPC)。   此前,泽倍珂?已获批用于治疗携带胚系和/或体系BRCA基因突变的转移性去势抵抗性前列腺癌成人患者(mCRPC)。BRCA突变前列腺癌通常恶性程度更高,患者预后不佳。作为国内首个且目前唯一针对BRCA突变前列腺癌的精准联合疗法,此次新适应症拓展填补了这部分患者亟待满足的临床治疗需求。   资料显示,近年来,我国前列腺癌的发病率呈现显著且持续的上升趋势,在男性恶性肿瘤中的总体排名已升至第六位。据预测,到2030年,前列腺癌将进入中国男性恶性肿瘤前三,成为高发常见肿瘤之一。据介绍,治疗策略的优化直接关乎患者长期生存,如若在mHSPC阶段未得到有效治疗,患者将很快进展至mCRPC,年全因死亡率由16%骤升至56% 。因此,在2026年NCCN、EAU及CSCO等国内外权威指南更新中,均以AMPLITUDE研究证据为依据,新增尼拉帕利联合阿比特龙的方案推荐,用于BRCA突变转移性内分泌治疗敏感性前列腺癌患者。(中国经济网记者 韩璐)   

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