吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐

金吾财讯
Jul 24

金吾财讯 | 吉利德科学(GILD)宣布,欧洲药品管理局(EMA)旗下人用药品委员会(CHMP)已发布积极意见,建议批准其Trop-2靶向ADC药物Trodelvy®联合帕博利珠单抗(Keytruda®),用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性(CPS ≥ 10)的不可切除局部晚期或转移性三阴性乳腺癌(TNBC)成人患者。

据介绍,CHMP的这一推荐基于关键3期临床试验(ASCENT-04/KEYNOTE-D19)的优异结果:1)无进展生存期(PFS): 相比“标准化疗 + Keytruda®”的对照组,Trodelvy®与Keytruda®联合疗法展现出在统计学与临床意义上的显著改善;2)疾病控制率:联合疗法将患者的疾病进展或死亡风险大幅降低了 35%。

若欧盟委员会(EC)于2026年晚些时候正式批准该联合疗法,Trodelvy®将实现从单药到联合疗法、全面覆盖不同PD-L1表达状态的mTNBC一线治疗布局。此前,Trodelvy®单药已在欧盟获批用于不适合接受PD-(L)1抑制剂治疗的mTNBC一线患者,且在美国已获得FDA对于单药及联合疗法的全面许可。

据悉,作为全球首创的Trop-2靶向ADC,Trodelvy®已在超过75,000名患者中积累了丰富的临床应用经验。随着其在欧洲一线治疗领域的进一步拓展,吉利德在肿瘤精准治疗领域的商业化护城河与营收增长动能有望得到进一步巩固。

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