BMS的PD-1单抗Opdivo首次获批治疗食道癌

2020-02-25 不详 MedSci原创

百时美施贵宝(Bristol-Myers Squibb)的PD-1单抗Opdivo首次获得批准用于治疗食道癌,此次在日本的获批早于美国。日本厚生劳动省(MHLW)批准Opdivo(nivolumab)用于治疗无法切除的晚期或复发的食管癌患者,这些患者在化疗后进展。

百时美施贵宝(Bristol-Myers Squibb)的PD-1单抗Opdivo首次获得批准用于治疗食道癌,此次在日本的获批早于美国。日本厚生劳动省(MHLW)批准Opdivo(nivolumab)用于治疗无法切除的晚期或复发的食管癌患者,这些患者在化疗后进展。

每年在日本诊断约20000例新的食道癌病例,并导致12000例死亡,Opdivo的此次批准不仅为BMS开辟了重要市场,而且为该预后较差的疾病患者提供了新的治疗选择。

MHLW根据3期ATTRACTION-3试验的结果批准了Opdivo,该试验评估了PD-1抑制剂与化学疗法(多西紫杉醇或紫杉醇)相比在氟嘧啶和铂类药物联合治疗无效或不耐受、不可切除的晚期或复发性食管鳞状细胞癌(ESCC)患者中的治疗效果。

Opdivo达到了总生存(OS)的主要终点,与化疗相比,死亡风险降低了23%,OS改善了2.5个月。不管肿瘤PD-L1表达水平如何,都观察到了Opdivo治疗的生存益处。

BMS的药物已经获得批准用于治疗多种癌症,包括黑色素瘤、小细胞肺癌、肾细胞癌等。

尽管Opdivo 是2015年第一个进入市场的检查点抑制剂,但由于Keytruda在非小细胞肺癌中的主导地位,Opdivo仍然在与Keytruda的竞争中不占优势。

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    2020-02-27 119337457
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    2020-02-27 canlab
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