FDA does not approve talazoparib plus enzalutamide for non-HRR gene mutated mCRPC

转移性阉割抵抗性前列腺癌（mCRPC）是前列腺癌进展的晚期阶段，预后较差，治疗选择有限。PARP抑制剂联合雄激素受体抑制剂为mCRPC患者带来了新的治疗希望，特别是对于携带同源重组修复（HRR）基因突变的患者。

他拉唑帕尼（Talzenna）是一种PARP抑制剂，恩杂鲁胺（Xtandi）是一种雄激素受体抑制剂。二者联合用于治疗HRR基因突变的mCRPC患者已获得FDA批准。TALAPRO-2的3期临床试验结果显示，与恩杂鲁胺单药治疗相比，他拉唑帕尼联合恩杂鲁胺显著延长了HRR基因突变mCRPC患者的放射学无进展生存期（rPBS）和总生存期（OS）。

然而，FDA近日拒绝批准他拉唑帕尼联合恩杂鲁胺用于治疗非HRR基因突变的mCRPC患者。FDA认为，TALAPRO-2试验中非HRR基因突变mCRPC患者亚组的数据不足以支持扩大适应症。尽管如此，FDA批准了该组合现有适应症的更新标签，纳入了TALAPRO-2试验的最终OS数据，进一步证实了该组合在HRR基因突变mCRPC患者中的疗效。虽然此次扩大适应症申请未获批准，但对于HRR基因突变的mCRPC患者来说，他拉唑帕尼联合恩杂鲁胺仍然是一个重要的治疗选择。未来的研究需要进一步探索该组合在非HRR基因突变mCRPC患者中的疗效和安全性，并寻找更有效的治疗策略。

来源: urologytimes

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