Relay Therapeutics宣布Zovegalisib获美国FDA突破性疗法认定,针对PIK3CA突变HR+/HER2-晚期乳腺癌

美股速递
Feb 03

Relay Therapeutics(纳斯达克代码:RLAY)今日宣布,其研发的Zovegalisib已获得美国食品药品监督管理局(FDA)授予的突破性疗法认定。该认定针对的是携带PIK3CA突变、激素受体阳性/人表皮生长因子受体2阴性(HR+/HER2-)的晚期乳腺癌患者。

突破性疗法认定旨在加速针对严重或危及生命疾病的新药开发和审评流程。Zovegalisib是一种口服PI3Kα抑制剂,其获得认定是基于早期临床数据所展现出的显著疗效和良好安全性。

此次认定标志着Zovegalisib在治疗这一特定乳腺癌亚型方面取得了重要进展,有望为患者提供新的治疗选择。

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