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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Vorasidenib：低级别胶质瘤患者的新希望还是虚假承诺？


尽管最近获得了 FDA 的批准，但 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，并强调了对照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且与标准治疗相比缺乏明显的益处，批准可能为时过早。