智通财经APP获悉,3月3日,中国国家药监局药品审评中心(CDE)官网公示,诺华(NVS.US)申报的1类新药[225Ac]Ac-PSMA-617注射液获批临床,拟开发治疗[177Lu]Lu-PSMA靶向治疗期间或之后进展的PSMA阳性转移性去势抵抗性前列腺癌。根据诺华官网管线资料可知,这是一款靶向PSMA的放射性配体疗法(研发代号:AAA817),已经在国际范围内进入2/3期临床研究阶段。本次是该产品首次在中国获批IND。
放射性药物近年来备受关注,其具有独特的“诊疗一体化”特点,可以用同一种肿瘤标志物为靶点,以针对该靶点的放射配体显像(RLI)技术对肿瘤病灶进行搜寻定位,再通过针对该靶点的放射配体疗法(RLT)药物对癌细胞实施精准打击,具有精准、高效、副作用较小等优势。
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