2020年10月20日07:00英国夏令时
前所未有的研究结果表明，用塔格利索治疗可以降低风险
在ADAURA III期试验中，疾病复发或死亡的风险降低了80%
澳门葡京网赌游戏公司 Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, 超过四分之三的患者被诊断为IIIA期, 五年内复发.1-4
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, 防止出现严重情况, 或者提高病人的依从性. 处方药使用者收费法案生效, FDA监管决定的行动日期, 是在2021年第一季度吗.
肿瘤事业部执行副总裁Dave Fredrickson说:“Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, 新的靶向治疗方案对于改善这些患者的预后至关重要. 这一快速审查强调了前所未有的无病生存益处 Tagrisso 为患者提供辅助治疗, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible.”
sNDA是基于ADAURA III期试验的结果 Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, 以及IB-IIIA期患者的总体试验人群, 一个关键的次要端点.
In 2020年4月, 一个独立数据监测委员会建议该试验提前两年开盲, 基于其压倒性功效的决定. 研究人员和患者继续参与试验，对治疗保持盲法. The results from the ADAURA trial were presented during the plenary session of the American Society of Clinical 肿瘤学 ASCO20 Virtual Scientific Program in 2020年5月 最近发表在 新英格兰医学杂志.
Tagrisso 获得突破性疗法称号 2020年7月. Tagrisso is approved for both the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, 日本, 中国, 欧盟和世界上许多其他国家.
肺癌
肺癌是男性和女性癌症死亡的主要原因, 占所有癌症死亡人数的五分之一.5 肺癌 is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.6 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.1-3
对于那些可切除的肿瘤, the majority of patients eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.4 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.7-8
在美国和欧洲大约有10-15%的NSCLC患者, 亚洲30-40%的患者有EGFRm.9-11 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells.12
ADAURA
ADAURA是一个随机的, 双盲, 全球, 在辅助治疗682例IB期患者的安慰剂对照III期试验, II, IIIA EGFRm NSCLC在肿瘤完全切除和辅助化疗后. 患者接受了 Tagrisso 80mg每日一次口服片剂或安慰剂，服用3年或直至疾病复发.
该试验在20多个国家的200多个中心进行, 包括美国在内, 在欧洲, 南美, 亚洲和中东. The primary endpoint is DFS in Stage II和IIIA患者 and 一个关键的次要端点 is DFS in Stage IB, II和IIIA患者. 该数据最初预计在2022年公布. 该试验将继续评估总生存期.
Tagrisso
Tagrisso (osimertinib)是第三代, 具有抗中枢神经系统转移临床活性的不可逆EGFR-TKI. Tagrisso 40mg和80mg每日一次口服片剂已在美国获得批准, 日本, 中国, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC.
澳门葡京网赌游戏治疗肺癌
澳门葡京网赌游戏 has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, 疾病的几个阶段, 治疗路线和作用方式.
澳门葡京网赌游戏 aims to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease with the approved medicines 艾瑞莎 (吉非替尼)和 Tagrisso 以及正在进行的LAURA、NeoADAURA和FLAURA2 III期临床试验.
澳门葡京网赌游戏 is committed to addressing tumour mechanisms of resistance through the ongoing SAVANNAH and ORCHARD Phase II trials, 哪些测试 Tagrisso 与savolitinib联合使用, c-MET受体酪氨酸激酶的选择性抑制剂, 还有其他潜在的新药.
澳门葡京网赌游戏在肿瘤学
澳门葡京网赌游戏 has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. 2014年至2020年间有7种新药上市, 还有大量正在开发的小分子和生物制剂, the Company is committed to advance oncology as a key growth driver for 澳门葡京网赌游戏 focused on lung, 卵巢, 乳腺癌和血癌.
通过利用六个科学平台的力量-免疫肿瘤学, 肿瘤驱动因素和耐药性, DNA损伤反应, 抗体药物偶联物, 表观遗传学和细胞疗法-并通过支持个性化组合的发展, 澳门葡京网赌游戏 has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
澳门葡京网赌游戏
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门葡京网赌游戏.com 并在推特上关注公司 @澳门葡京网赌游戏.
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参考文献
1. 礼物, 等. 肺癌生物标志物:现状与未来发展. 档案病理学实验室. 2013;137:1191-1198.
2. 骑士T. 可切除非小细胞肺癌的辅助化疗:何去何从? 安杂志. 2010;21:196-8.
3. 达塔, 等. 肺切除术患者的术前评价. 胸部. 2003;123: 2096–2103.
4. Pignon 等. 肺辅助顺铂评价:一项由LACE合作小组进行的汇总分析. J .临床肿瘤学 2008;26:3552-3559.
5. 世界卫生组织. 国际癌症研究机构. 肺部情况说明. 可以在 http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. 2020年8月.
6. LUNGevity基金会. 肺癌的种类. 可以在 http://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer. 2020年8月.
7. Sethi年代, 等. 偶发结节的管理——应该有一个正式的过程吗?. 胸外科杂志. 2016:8;S494-S497.
8. LUNGevity基金会. 筛查和早期发现. 可以在: http://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection#1. 2020年8月.
9. Szumera-Ciećkiewicz一等。. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, 欧洲发病率的单机构研究和系统评价. 临床经验病理学. 2013:6;2800-12.
10. Keedy六世, 等. American Society of Clinical 肿瘤学 Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J .临床肿瘤学. 2011:29;2121-27.
11. 埃里森G, 等. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. 临床病理学. 2013:66;79-89.
12. 交叉哒。 等. AZD9291, 一个不可逆的EGFR TKI, 克服t790m介导的肺癌对EGFR抑制剂的耐药. 癌症越是加大. 2014;4(9):1046-1061.
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