强生宣布中国首个且目前唯一治疗BRCA突变转移性去势抵抗性前列腺癌的复方制剂泽倍珂®在华获批

BRCA 去势抵抗性前列腺癌泽倍珂

强生创新制药

10/21

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泽倍珂^®是每日一次的口服复方制剂，用于联合泼尼松或泼尼松龙一线治疗携带BRCA1/2突变的转移性去势抵抗性前列腺癌成人患者，临床证实其相较标准治疗可显著延长影像学无进展生存期^[2]。

强生公司今日宣布，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。作为目前国内首个且唯一获批的双效复方制剂^[1]，泽倍珂®联合泼尼松或泼尼松龙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）^[3]。

泽倍珂®是BRCA1/2突变mCRPC成人患者的一线靶向治疗方案^[4]。作为一种高选择性聚腺苷二磷酸核糖聚合酶(PARP)抑制剂^[5]，尼拉帕利和醋酸阿比特龙的组合联合泼尼松或泼尼松龙，能够靶向mCRPC患者的两种致癌驱动因素——雄激素受体轴和BRCA1/2突变^[3][6][7]。经临床验证，泽倍珂®联合泼尼松或泼尼松龙可显著延长BRCA1/2突变mCRPC患者的影像学无进展生存期（rPFS）。此外，与安慰剂相比，尼拉帕利还显示出总体生存 (OS)改善的趋势，可显著延长至症状进展时间（TSP）和至细胞毒性化疗起始时间（TCC），同时并维持了患者的生活质量^[8]。

近年来，中国前列腺癌的发病率显著上升。据国家癌症中心最新发布的2022年度中国恶性肿瘤疾病负担报告显示，我国前列腺癌的发病率为每10万人中18.61例，已成为男性泌尿生殖系统中最常见的肿瘤^[9]。尽管随着我国医疗水平的提高，前列腺癌的治疗已经取得一定进展，但是mCRPC仍然是一种致命的疾病^[10][11]。据统计，大约10-15%的mCRPC患者携带BRCA1/2基因突变^[12][13]，而携带BRCA1/2基因突变的前列腺癌往往恶性程度更高，可能具有更强的侵袭性和更高的转移性疾病比例，患者的生存结局更差^{[14][15][16][17][18]}。因此，NCCN和EAU等国内外权威指南均推荐对mCRPC患者进行基因检测，以提供更加精准的治疗决策，改善患者临床获益^[19][20]。

强生创新制药中国区总裁黄琛女士表示：“泽倍珂^®的获批再次印证了前列腺癌精准治疗时代的到来，突显了基因检测在前列腺癌诊疗中的重要意义。长期以来，强生始终关注不同疾病阶段前列腺癌患者的切实需求，持续引入创新疗法及产品组合，从前列腺癌的晚期治疗，进一步覆盖到更早期阶段。同时，我们也希望让更多患者实现前列腺癌全程管理，在早期、规范化、足疗程的诊疗中获得更长生存。”

CP-482114 Approved Date: 2024-10-16

参考文献

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