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安进创新胃癌一线疗法bemarituzumab获美国FDA突破性疗法认定

2021-04-21 生物探索 生物探索

FGFR2b抗体疗法bemarituzumab

今日,安进(Amgen)公司宣布,旗下在研FGFR2b抗体疗法bemarituzumab获美国食品药品监督管理局(FDA)突破性疗法认定。该疗法将与化疗组合联用,用于一线治疗HER2阴性局部晚期或转移性胃癌和胃食管结合部(GEJ)癌患者。

胃癌(gastric carcinoma)是起源于胃黏膜上皮的恶性肿瘤,在我国各种恶性肿瘤中发病率居首位。据统计,2020年一整年的胃癌死亡人群就达到37万人。

bemarituzumab是由Five Prime Therapeutics公司研制的一款首创(first-in-class)靶向抗体,可阻止FGF结合和激活FGFR2b,抑制多种下游促肿瘤信号通路,并可能延缓癌症进展。

据悉,早在2017年12月,Five Prime Therapeutics就授予了再鼎医药在大中华区开发和商业化bemarituzumab的独家许可。今年3月,安进公司斥资19亿美元收购了Five Prime Therapeutics公司,将bemarituzumab疗法纳入旗下,并填补了安进在肿瘤创新疗法管线的空白。

值得一提的是,该抗体疗法bemarituzumab是安进公司继首款靶向KRAS G12C突变的药物Sotorasib(AMG 510)后,近6个月内第二款获得突破性疗法认定的产品。

据悉,该突破性疗法认定的授予是基于一项名为FIGHT的2期临床试验的积极结果,且该试验是首个评估靶向肿瘤中FGFR2b过表达的研究。

临床结果显示,bemarituzumab与化疗联用,在至少10%肿瘤细胞过度表达FGFR2b的患者亚群中,显着改善患者的无进展生存期和总生存期,且临床获益与FGFR2b阳性的肿瘤细胞比例有正相关性。

未来,期待安进进一步研究FGFR2b的作用,并继续与监管机构合作,将这一潜在的first-in-class一线疗法带给患者。

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    2022-01-28 snf701207
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    2021-04-23 fengyi812
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    2021-04-22 科研科研科研

    安进公司的产品

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