默沙東「PD-1抑制劑可瑞達(dá)?」新適應(yīng)癥在華獲批
2024年6月25日,默沙東宣布,其PD-1抑制劑帕博利珠單抗(商品名:可瑞達(dá)?)已獲得中國國家藥品監(jiān)督管理局(NMPA)批準(zhǔn)聯(lián)合曲妥珠單抗、含氟尿嘧啶類和鉑類藥物化療,用于經(jīng)充分驗(yàn)證的檢測評(píng)估腫瘤表達(dá)PD-L1(綜合陽性評(píng)分(CPS)≥1)的局部晚期不可切除或轉(zhuǎn)移性HER2陽性胃或胃食管結(jié)合部腺癌患者的一線治療。此次新適應(yīng)證的獲批是基于全球III期臨床試驗(yàn)KEYNOTE-811的數(shù)據(jù)。
根據(jù)WHO發(fā)布的最新數(shù)據(jù),中國每年胃癌新增病例數(shù)約35.8萬例,死亡病例數(shù)約26萬例1。絕大多數(shù)的胃癌是腺癌,約占到95%以上2。中國胃癌患者早期占比很低,僅約20%,大多數(shù)患者發(fā)現(xiàn)時(shí)已是進(jìn)展期3,而晚期胃癌五年生存率不到10%4。
若您想了解更多有關(guān)疾病知識(shí)的信息,請(qǐng)咨詢醫(yī)療衛(wèi)生專業(yè)人士
文獻(xiàn)參考:
1.World Heath Organization, IARC, Globocan 2022. Cancer Today: China Fact Sheet
2.馬乾宸, 張本炎, 芮煒瑋, 王婷, 羅方秀, 王朝夫, 袁菲. 中國3 071例胃癌病理分型分析[J]. 診斷學(xué)理論與實(shí)踐, 2022, 21(05): 560-566.
3.中華人民共和國國家衛(wèi)生健康委員會(huì)醫(yī)政醫(yī)管局. (2022) 胃癌診療指南 http://www.nhc.gov.cn/yzygj/s7659/202204/a0e67177df1f439898683e1333957c74/files/dfc6063ce0a441a5b6d9c7350cac2c2a.pdf
4.Li H, Zhang H, Zhang H, Wang Y, Wang X, Hou H; Global Health Epidemiology Reference Group. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health. 2022 Dec 17;12:11014. doi: 10.7189/jogh.12.11014. PMID: 36527356; PMCID: PMC9759711.
5.中國抗癌協(xié)會(huì)胃癌專業(yè)委員會(huì), 中國抗癌協(xié)會(huì)腫瘤內(nèi)鏡學(xué)專業(yè)委員會(huì). 胃癌胃鏡活檢標(biāo)本HER-2檢測中國專家共識(shí)(2023版)[J]. 中國腫瘤臨床, 2023, 50(19): 973-982. doi: 10.12354/j.issn.1000-8179.2023.20230961
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7.Sheng WQ, Huang D, Ying JM, Lu N, Wu HM, Liu YH, Liu JP, Bu H, Zhou XY, Du X. HER2 status in gastric cancers: a retrospective analysis from four Chinese representative clinical centers and assessment of its prognostic significance. Ann Oncol. 2013 Sep;24(9):2360-4. doi: 10.1093/annonc/mdt232. Epub 2013 Jun 19. PMID: 23788757.
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9.Kawakami T, Yamazaki K. Recent Progress in Treatment for HER2-Positive Advanced Gastric Cancer. Cancers (Basel). 2024 Apr 30;16(9):1747. doi: 10.3390/cancers16091747. PMID: 38730700; PMCID: PMC11083522.
來源:默沙東中國官微


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