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金斯瑞生物科技(01548.HK):美國FDA接受優先審查西達基奧侖賽(cilta-cel)生物製品許可申請
格隆匯 05-27 06:13

格隆匯5月27日丨金斯瑞生物科技(01548.HK)公吿,公司非全資附屬公司傳奇生物科技股份有限公司於2021年5月26日宣佈美國食品藥品監督管理局(FDA)已接受優先審查西達基奧侖賽(cilta-cel)的生物製品許可申請(BLA)。cilta-cel是一種在研的靶向BCMA的CAR-T療法。根據處方藥使用者付費法案(PDUFA),FDA將在2021年11月29日前完成對該BLA的審查。

優先審查通常適用於能明顯改善重大疾病的治療、預防或診斷的在研療法。此前,ciltacel已於2019年12月獲得突破性治療藥物認定,該認定旨在加快潛在新藥的開發和審查。

cilta-cel提交監管審查是基於關鍵性lb/2期CARTITUDE-1研究的結果,該研究評估了ciltacel在治療復發和╱或難治性多發性骨髓瘤患者中的有效性和安全性。最新的18個月隨訪資料將於下個月舉辦的2021年美國臨牀腫瘤學會(ASCO)年會(摘要#8005)及歐洲血液病學會(EHA)虛擬會議(摘要#EP964)上發佈。

公司相信根據目前掌握的臨牀試驗資料,cilta-cel有望用於接受過多重治療的多發性骨髓瘤患者。優先審查接受是一個重要的里程碑。與傳奇生物的合作伙伴楊森一起,集團期待與FDA共同將這項革命性療法提供給需要有效的新療法的患者。

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