辉瑞择捷美第五个适应症获批，成为首个治疗胃癌的PD-L1抑制剂

新民晚报03-15

辉瑞公司今天宣布，肿瘤免疫创新药择捷美（舒格利单抗注射液）已获国家药品监督管理局（NMPA）批准，联合含氟尿嘧啶类和铂类药物化疗用于表达PD-L1（综合阳性评分[CPS]≥5）的不可手术切除的局部晚期或转移性胃及胃食管结合部腺癌（G/GEJ）的一线治疗，成为全球首个在胃/胃食管结合部腺癌适应症获批的PD-L1单抗。这是继食管鳞癌之后，择捷美于近期在上消化道肿瘤领域获批的第二项适应症，也是择捷美自...

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cancer","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1,"PD":1},"content_text":"辉瑞公司今天宣布，肿瘤免疫创新药择捷美（舒格利单抗注射液）已获国家药品监督管理局（NMPA）批准，联合含氟尿嘧啶类和铂类药物化疗用于表达PD-L1（综合阳性评分[CPS]≥5）的不可手术切除的局部晚期或转移性胃及胃食管结合部腺癌（G/GEJ）的一线治疗，成为全球首个在胃/胃食管结合部腺癌适应症获批的PD-L1单抗。这是继食管鳞癌之后，择捷美于近期在上消化道肿瘤领域获批的第二项适应症，也是择捷美自2021年以来获批的第五项适应症。胃癌是来源于胃黏膜上皮细胞的恶性肿瘤，也是我国最常见的癌症之一。据GLOBOCAN 2020数据，2020年全球每年新发胃癌病例超过100万例，死亡病例达76.9万例，而中国每年新发胃癌病例和死亡病例数都接近全球的一半。在中国的胃癌病例中，90%以上是胃腺癌，且胃食管结合部腺癌在全球及中国范围内的发病率均呈现上升趋势。值得关注的是，我国早期胃癌占比很低，大多数患者在发现时已处于进展期，5年生存率不足50%。“中国是全球胃癌疾病负担最严重的国家之一，临床上，大部分胃腺癌患者在初诊时已经进入晚期阶段，无法进行手术切除，并且晚期或转移性胃癌患者的预后通常较差，存在巨大的未满足的医疗需求。”择捷美GEMSTONE-303研究主要研究者、北京大学肿瘤医院沈琳教授表示：“择捷美是首个获批的明确胃癌生物标志物的PD-L1单抗，无疑将为G/GEJ患者的精准治疗提供更多选择。希望择捷美能尽快投入临床应用，为更多胃癌患者带来治疗的新希望。”截至目前，择捷美在国内已相继获批五项适应症，包括IV期和III期非小细胞肺癌（NSCLC）、复发或难治性结外NK/T细胞淋巴瘤（R/R ENKTL）、不可切除的局部晚期、复发或转移性食管鳞癌以及局部晚期或转移性胃/胃食管结合部腺癌，其中在IV期NSCLC、胃癌和食管鳞癌这些我国高发的肿瘤领域，均为一线疗法。未来，择捷美将持续发挥在肿瘤免疫治疗领域的潜力，为肿瘤患者提供创新的治疗方案。新民晚报记者 左妍","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2419091108"}