百濟神州(688235.SH):歐盟委員會批准百澤安用於三項非小細胞肺癌適應症的一線及二線治療
格隆匯4月23日丨百濟神州(688235.SH)公佈,近日獲悉,歐盟委員會已授予百澤安(替雷利珠單抗注射液)上市許可,批准其用於三項非小細胞肺癌(NSCLC)適應症的一線及二線治療:聯合紫杉醇和卡鉑或注射用紫杉醇(白蛋白結合型)和卡鉑用於不適合手術切除或接受含鉑放化療的局部晚期或轉移性鱗狀非小細胞肺癌成人患者的一線治療;聯合培美曲塞和鉑類化療用於PD-L1表達≥50%且無表皮生長因子受體(EGFR)或間變性淋巴瘤激酶(ALK)陽性突變、不適合手術切除或接受含鉑放化療的局部晚期或轉移性非鱗狀非小細胞肺癌成人患者的一線治療;單藥用於治療既往接受含鉑藥物治療後的局部晚期或轉移性NSCLC成人患者。EGFR突變或ALK突變陽性的NSCLC患者在接受替雷利珠單抗治療前應當已接受過靶向治療。
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