百濟神州(06160.HK):國家藥監局批准百澤安®用於食管鱗狀細胞癌的二線治療
格隆匯4月19日丨百濟神州(06160.HK)2022年4月15日宣佈,中國國家藥品監督管理局(NMPA)已批准其抗PD-1抗體藥物百澤安® (替雷利珠單抗注射液)用於治療既往接受過一線標準化療後進展或不可耐受的局部晚期或轉移性食管鱗狀細胞癌(ESCC)患者。
百濟神州高級副總裁、實體瘤首席醫學官Mark Lanasa醫學博士表示:“我們在針對二線ESCC的全球3期臨牀試驗中觀察到,百澤安®這一具有差異化的檢查點抑制劑顯著改善了患者的總生存期且總體耐受性良好。在美國和歐盟,針對該適應症的註冊申報已由我們的合作伙伴諾華提交,且已經獲得美國食品藥品監督管理局(FDA)及歐洲藥品管理局(EMA)的受理,目前正在審評中。這再一次印證了我們努力加快百澤安®的研發進展,以造福全球腫瘤患者的承諾。”
百濟神州公司總裁、首席運營官兼中國區總經理吳曉濱博士表示:“此次新適應症的獲批對於我國ESCC患者而言,無疑是又一意義重大的進展。作為一款重要的免疫治療方案,百澤安®已在中國獲批八項適應症。我們立足於科學的商業化團隊已超過3,100人,將繼續致力於把百澤安®帶給更多有望從中獲益的患者。”
該試驗的主要研究者、北京大學腫瘤醫院副院長沈琳教授表示:“食管癌是消化道領域最常見的惡性腫瘤之一。全球3期臨牀試驗RATIONALE302的結果顯示了百澤安®作為二線治療方案,對於ESCC患者的有效性和安全性。百澤安®這一適應症獲得NMPA批准,對於既往接受過治療的ESCC患者來説是一個好消息,我們很高興能夠為患者帶來更多治療新選擇。”
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