智通财经APP获悉,4月28日,中国国家药监局药品审评中心(CDE)官网最新公示,诺华(NVS.US)申报的镥[177Lu] 特昔维匹肽注射液一项新适应症上市申请获得受理。公开资料显示,这是诺华研发的靶向PSMA的放射配体疗法(RLT)Pluvicto(lutetium Lu 177 vipivotide tetraxetan) 。该药此前已经在中国申报首个适应症上市申请,并被CDE纳入优先审评,用于治疗PSMA阳性转移性去势抵抗性前列腺癌(mCRPC) 、已接受雄激素受体通路抑制和紫杉类化疗的成年患者。
根据诺华公开资料可以推测,本次该药申报上市的适应症为:用于更早线未经化疗的PSMA阳性的mCRPC患者。针对该项适应症,Pluvicto于今年4月获得了美国FDA批准。
Pluvicto是通过静脉注射的放射配体疗法(RLT),由靶向配体与治疗性放射性核素(镥-177)结合而成。进入血液后,Pluvicto可靶向结合表达PSMA的前列腺癌细胞。结合后,放射性同位素释放的能量可破坏靶细胞,抑制其复制能力和/或引发肿瘤细胞死亡。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.