雲頂新耀-B(01952.HK):創新藥戈沙妥組單抗被國藥監局納入優先審評品種
格隆匯5月20日丨雲頂新耀-B(01952.HK)公佈,中國國家藥品監督管理局藥品審評中心將戈沙妥組單抗(sacituzumab govitecan-hziy)納入優先審評品種。
此次獲准被納入優先審評品種是繼公司於2021年5月17日刊發的公吿公佈中國國家藥品監督管理局已受理戈沙妥組單抗(sacituzumab govitecan-hziy)的生物製品上市許可申請後取得的又一新進展。戈沙妥組單抗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(至少其中之一為轉移性疾病)成年患者。2020年10月,戈沙妥組單抗被納入到2020版《中國晚期乳腺癌規範診療指南》,該指南由國家腫瘤質控中心乳腺癌專家委員會、中國抗癌協會乳腺癌專業委員會、中國抗癌協會腫瘤藥物臨牀研究專業委員會共同編撰。
戈沙妥組單抗的英文商品名為Trodelvy®,2020年4月獲得了美國食品藥物管理局的加速批准,並於2021年4月又進一步獲得了完全批准,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,至少其中之一為轉移性疾病。
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