Cogent Biosciences公司近日宣布，其研发药物贝珠拉替尼（bezuclastinib）与舒尼替尼（sunitinib）联合治疗方案，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（Breakthrough Therapy Designation），适应症为胃肠道间质瘤（GIST）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。此次认定基于临床数据显示，该联合疗法在GIST治疗中展现出显著疗效。
这一里程碑标志着Cogent Biosciences在肿瘤靶向治疗领域取得重要进展，也为GIST患者提供了新的潜在治疗选择。
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