智通财经APP获悉,8月22日,CDE官网显示,强生(JNJ.US)尼拉帕利阿比特龙片新适应症上市申请获受理。根据公开资料和临床进展,外界推断本次申报上市的适应症为激素依赖性前列腺癌。
公开资料显示,尼拉帕利阿比特龙是强生推出的复方制剂,于2023年先后在欧盟、美国获批上市,用于联合泼尼松或泼尼松龙治疗BRCA1/2突变的转移性去势抵抗性前列腺癌成人患者(mCRPC)一线治疗。2024年10月,该药首次在国内获批上市,成为国内首个且唯一获批的双效复方制剂。
安全性方面,3/4级不良事件(AE)在试验组中发生率为75.2%,在对照组中发生率为58.9%,最常见的是贫血和高血压。因AE导致的停药的发生率较低(11.0% vs 6.9%)。
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