7月29日，据百济神州官微消息，7月28日，公司宣布欧洲药品管理局(EMA)人用药品委员会(CHMP)发布积极意见，推荐批准百泽安®(替雷利珠单抗)联合含铂化疗用于存在高复发风险的可切除非小细胞肺癌(NSCLC)成人患者的术前新辅助治疗，并在术后继续使用替雷利珠单抗单药进行辅助治疗。该推荐基于3期RATIONALE-315研究(NCT04379635)结果。
据介绍，替雷利珠单抗已在欧盟获批的肺癌相关适应症包括：用于鳞状NSCLC患者一线治疗；用于PD-L1高表达的非鳞状NSCLC患者一线治疗；用于既往接受过含铂治疗的局部晚期或转移性NSCLC患者治疗；用于广泛期小细胞肺癌患者一线治疗。此外，获批适应症还包括：用于胃或胃食管结合部腺癌患者一线治疗；用于不可切除的食管鳞状细胞癌(ESCC)患者一线治疗；用于既往接受过含铂化疗的ESCC患者二线治疗；用于鼻咽癌患者一线治疗。
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