Guardant Health获FDA批准Guardant360® Cdx作为Arvinas与辉瑞Veppanu（Vepdegestrant）的伴随诊断工具适用于携带ESR1突变的ER+/HER2-晚期乳腺癌患者

美股速递05-04 20:05

Guardant Health公司宣布，其Guardant360® Cdx液体活检产品已获得美国食品药品监督管理局（FDA）的批准，可作为Arvinas与辉瑞共同开发的Veppanu（Vepdegestrant）的伴随诊断工具。该批准专门针对携带ESR1突变的雌激素受体阳性/人表皮生长因子受体2阴性（ER+/HER2-）晚期乳腺癌患者群体。

此次获批意味着临床医生能够通过Guardant360® Cdx这一血液检测技术，精准识别出最可能从Veppanu（Vepdegestrant）靶向治疗中获益的患者。该诊断工具通过检测循环肿瘤DNA中的ESR1突变，为个体化治疗决策提供了关键依据，标志着晚期乳腺癌精准医疗领域的重要进展。

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Guardant Health获FDA批准Guardant360® Cdx作为Arvinas与辉瑞Veppanu（Vepdegestrant）的伴随诊断工具 适用于携带ESR1突变的ER+/HER2-晚期乳腺癌患者

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Guardant Health获FDA批准Guardant360® Cdx作为Arvinas与辉瑞Veppanu（Vepdegestrant）的伴随诊断工具适用于携带ESR1突变的ER+/HER2-晚期乳腺癌患者