Despite recent FDA approval, the clinical utility of vorasidenib in the treatment of IDH-mutant low-grade gliomas remains unclear. Herein, we critique the pivotal trial of vorasidenib, and highlight the questionable choice of control intervention and end points, ethical concerns, as well as the uncertain efficacy observed, and argue that the approval might be premature given the high cost of this drug and lack of clear benefit over standard treatments.

中文翻译：

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沃拉西尼：对低级别胶质瘤患者来说是新的希望还是虚假的承诺？


尽管最近 FDA 批准了 vorasidenib 在治疗 IDH 突变低级别胶质瘤中的临床效用仍不清楚。在此，我们批评了 vorasidenib 的关键试验，并强调了控制干预和终点的可疑选择、伦理问题以及观察到的不确定疗效，并认为鉴于该药物的高成本和缺乏证据，批准可能为时过早。与标准治疗相比具有明显的益处。