雲頂新耀-B(01952.HK):Trodelvy®獲FDA完全批准用於治療接受過既往治療的局部不可切除晚期或者轉移性三陰性乳腺癌
格隆匯 4 月 9日丨雲頂新耀-B(01952.HK)發佈公吿,美國食品藥品管理局(FDA)完全批准了吉利德科學公司(納斯達克代碼:GILD)旗下藥物Trodelvy®(通用名:sacituzumab govitecan-hziy)用於治療至少接受過兩線或以上既往治療的局部不可切除晚期或者轉移性三陰性乳腺癌(TNBC),至少其中之一為轉移性疾病。吉利德科學公司是公司的合作伙伴。
此次獲批是基於3期ASCENT研究資料。該項研究顯示了與化療相比,Trodelvy®不僅具有顯著的統計學意義,同時在臨牀上也有實質意義地大幅將患者的疾病惡化或死亡風險降低57%,中位無惡化進展生存期從1.7個月延長至4.8個月(風險比(HR):0.43;95% CI: 0.35–0.54;p<0.0001)。Trodelvy®同時延長中位數總體生存期從6.9個月至11.8個月(風險比 (HR):0.51;95% CI:0.41–0.62;p<0.0001),降低死亡風險49%。
在與吉利德科學公司簽署的授權引進協議中,公司在大中華區、南韓和部分東南亞國家享有針對所有癌症適應症開發、註冊和商業化sacituzumab govitecan-hziy的獨家權利。
公司正在中國開展sacituzumab govitecan-hziy用於治療至少接受過兩線既往治療的轉移性三陰性乳腺癌患者的2b期關鍵性臨牀試驗。此外,公司2021年1月份公佈已向新加坡衞生科學局(HAS)提交sacituzumab govitecan-hziy用於治療至少接受過兩線既往治療的轉移性三陰性乳腺癌患者的新藥上市申請(NDA),目前該申請正在審理中。
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