PD-L1单抗Bavencio:正在欧洲接受审查以治疗转移性尿路上皮癌

2020-06-22 MedSci原创 MedSci原创

欧洲药品管理局正在审查默克和辉瑞的PD-L1单抗Bavencio(avelumab),用作局部晚期或转移性尿路上皮癌(UC)患者的一线维持治疗。

欧洲药品管理局正在审查默克和辉瑞的PD-L1单抗Bavencio(avelumab),用作局部晚期或转移性尿路上皮癌(UC)患者的一线维持治疗。

See the source image

在欧盟,每年有近200000人被诊断出患有膀胱癌,其中60000人因该病而丧生,突显出该疾病领域极大未满足的需求。

膀胱癌患者有90%为尿道上皮癌,随着疾病发展越来越难以治疗,并可能扩散到膀胱壁各层。转移后,该疾病的五年生存率仅为5%。

来自JAVELIN Bladder 100 III期研究的数据表明,在PD-L1阳性、未经治疗的局部晚期或转移性尿路上皮癌(UC)患者中,Bavencio可以显着改善患者的总体生存率,从而为该类患者拥有新的一线治疗选择带来了希望。

在欧洲,该药物已被批准与axitinib联合用于成人晚期肾细胞癌(RCC)的一线治疗,并作为默克尔细胞癌的单一疗法。

原始出处:

http://www.pharmatimes.com/news/ema_to_consider_expanding_use_of_merckpfizers_bavencio_1342613

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    2020-06-24 smartjoy
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Seattle Genetics和Astellas的抗体偶联药物enfortumab vedotin治疗局部晚期或转移性尿路上皮癌,喜获FDA的优先审查

Seattle Genetics和Astellas Pharma(安斯泰来)宣布,美国食品和药物管理局(FDA)已接受其抗体偶联药物enfortumab vedotin的生物制剂许可申请(BLA)并授予优先审查治疗局部晚期或转移性尿路上皮癌患者,这些患者已接受PD-1 / L1抑制剂,并且在新辅助/辅助,局部晚期或转移性环境中接受含铂化疗。

默克和辉瑞的抗PD-L1单抗Bavencio改善了局部晚期或转移性尿路上皮癌患者的生存率:III期临床达到主要终点

默克和辉瑞公司周一宣布,其PD-L1单抗新药Bavencio(avelumab)用于先前未经治疗的局部晚期或转移性尿路上皮癌患者一线维持治疗的III期研究在中期分析达到了其总体生存率(OS)的主要终点。两家公司指出,在这种情况下,抗PD-L1单抗是首个显着延长OS的免疫疗法。

FDA授予ADC药物sacituzumab govitecan快速通道指定,用于治疗转移性尿路上皮癌

Sacituzumab govitecan是一种新型的抗体药物偶联物(ADC),由靶向TROP-2抗原的人源化IgG1抗体与化疗药物伊立替康(一种拓扑异构酶I抑制剂)的代谢活性产物SN-38偶联而成。