2020年11月20日07:00 GMT
四周剂量现已批准用于所有Imfinzi适应症, 减少就医次数，提高患者便利性
澳门在线赌城娱乐公司 Imfinzi (durvalumab)已在美国获得批准，作为一种额外的剂量选择, a 1,每4周固定剂量500mg, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced 膀胱癌. 这个新选项与已批准的选项一致 Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.
美国食品和药物管理局(FDA)的批准是基于来自几个国家的数据 Imfinzi 临床试验, 包括支持为期两周的PACIFIC III期试验, 不可切除的III期NSCLC中基于体重的剂量, 以及使用4周的CASPIAN III期试验, ES-SCLC维持治疗期间固定给药. 该决定是在 优先审核 FDA于2020年8月批准的.
维多利亚米. Villaflor, MD, Clinical Professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, 洛杉矶, 加州, said: “This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients. 另外, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19.”
戴夫Fredrickson, 执行副总裁, 肿瘤事业部, said: “The approval of this new dosing option across indications reflects our ongoing commitment to improve the patient experience and ensure continuity of care - a priority at all times, 尤其是在大流行期间. 巨蟹座不会等待, and it is our job to provide patients with treatment options that acknowledge the challenges the pandemic poses to cancer care, enabling them to visit their physician when truly needed and avoid preventable exposure to healthcare-associated infections.”
4周1500毫克固定剂量的选择 Imfinzi 是否也在其他几个国家接受监管审查, 包括在欧盟，新的剂量选择被授予加速评估.
Imfinzi 在不可切除的治疗目的下被批准吗, 在美国，CRT后的III期NSCLC, 在欧盟, in Japan, 在中国和许多其他国家, 基于太平洋III期试验. Imfinzi is also approved for previously treated patients with advanced 膀胱癌 in the US and several other countries. 另外, 它在美国是被批准的, the EU, Japan and several other countries around the world for the treatment of ES-SCLC based on the CASPIAN Phase III trial.
III期非小细胞肺癌
III期NSCLC(局部晚期)通常分为三个亚类(IIIA), iib及IIIC), 根据癌症局部扩散的程度和手术的可能性来确定.1 III期疾病不同于IV期疾病, 癌症扩散(转移)的部位, 因为目前大多数III期患者的治疗目的是治愈.1,2
III期非小细胞肺癌 represents approximately one third of NSCLC incidence and in 2015 was estimated to affect nearly 200,在以下8个大国，000名患者:中国, France, Germany, Italy, Japan, Spain, UK, 和美国, 大约有43个,仅在美国就有5000个病例.3,4 大多数III期非小细胞肺癌患者被诊断为不可切除的肿瘤.5 在批准之前 Imfinzi 在这种情况下，几十年来，除了CRT之外，没有新的治疗方法可供患者使用.6-8
小细胞肺癌
SCLC是一个非常激进的组织, 一种生长迅速的肺癌，通常复发和进展迅速, 尽管最初对化疗有反应.9,10 大约三分之二的SCLC患者被诊断为广泛期疾病, 在这种情况下，癌症已经通过肺部或身体其他部位广泛扩散.11 预后特别差, 因为只有6%的SCLC患者在诊断后的5年内存活.11
膀胱癌
In 2018, 大约有550,全世界有000人被诊断患有膀胱癌，200人被诊断患有膀胱癌,000人死于这种疾病.12 Locally advanced and metastatic 膀胱癌 remains an area of unmet medical need and typically only one in seven patients is alive five years after diagnosis.13 尿路上皮癌(UC)是膀胱癌最常见的形式.14 UC是全球第10大常见癌症，也是第13大常见癌症死亡原因.12,15 PD-L1 is widely expressed in tumour and immune cells in patients with 膀胱癌 and helps tumours evade detection from the immune system.16
Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
作为广泛发展计划的一部分， Imfinzi 是否正在进行单药治疗和包括tremelimumab在内的联合治疗试验, 抗ctla4单克隆抗体及潜在新药, 作为非小细胞肺癌的一种治疗方法, SCLC, 膀胱癌, 头颈癌, 肝癌, 胆道癌, 食道癌, 胃癌, 子宫颈癌, 卵巢癌, 子宫内膜癌及其他实体瘤.
澳门在线赌城娱乐治疗肺癌
澳门在线赌城娱乐 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.
An extensive Immuno-Oncology (IO) development programme focuses on lung cancer patients without a targetable genetic mutation, 占肺癌患者总数的四分之三.17 Imfinzi, 抗pdl1抗体, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier 疾病的阶段, 包括潜在的治疗设置(美人鱼-1), AEGEAN, 辅助BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or 化疗.
Imfinzi NeoCOAST的II期临床试验也在进行中, COAST和HUDSON与早期研发的潜在新药联合使用, 包括 Enhertu (曲妥珠单抗deruxtecan).
澳门在线赌城娱乐的IO方法
IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. 澳门在线赌城娱乐 is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.
该公司正在进行一个全面的临床试验项目，包括 Imfinzi 作为单一疗法或与tremelimumab联合治疗多种肿瘤类型, 疾病的阶段, 以及治疗方法, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. 除了, 将IO组合与辐射相结合的能力, 化疗, 来自澳门在线赌城娱乐肿瘤产品线的小靶向分子, 从研究伙伴那里, 可能为广泛的肿瘤提供新的治疗选择.
澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐 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 澳门在线赌城娱乐 focused on lung, ovarian, 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, 澳门在线赌城娱乐 has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，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, Renal & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在Twitter上关注公司 @澳门在线赌城娱乐.
Contacts
参考文献
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2. Cheema PK, et al. Perspectives on Treatment Advances For Stage III Locally Advanced Unresectable Non-Small-Cell Lung Cancer. 咕咕叫杂志. 2019;26(1):37-42.
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8. Hanna N, et al. Current Standards and Clinical Trials in Systemic Therapy for Stage III Lung Cancer: What is New? 我是社会学家吗. 2015:e442-447.
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10. 国家癌症研究所. NCI词典-小细胞肺癌. 可以在 http://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. 2020年11月访问.
11. Cancer.Net. 肺癌-小细胞. 可以在 http://www.cancer.net/cancer-types/lung-cancer-small-cell. 2020年11月访问.
12. 世界卫生组织国际癌症研究机构. 癌症概况-膀胱. 可以在 http://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf. 2020年9月访问.
13. 冯·德·马斯， et al. 一项比较吉西他滨和顺铂的随机试验的长期生存结果, 与甲氨蝶呤, 长春花碱, 阿霉素, 联合顺铂治疗膀胱癌. J .临床肿瘤学. 2005;23:4602-4608.
14. 美国临床肿瘤学会. 膀胱癌:介绍. 可以在 http://www.cancer.net/cancer-types/bladder-cancer/introduction. 2020年9月访问.
15. 世界癌症研究基金. 膀胱癌统计数字. 可以在 http://www.wcrf.org/dietandcancer/cancer-trends/bladder-cancer-statistics. 2020年9月访问.
16. 抹大拉, et al. 膀胱癌免疫应答:免疫细胞群的作用, 预后因素和治疗意义. 前肿瘤防治杂志. 2019;9:1270.
17. Pakkala,年代, et al. 肺癌的个性化治疗:击中一个移动的目标. 江森自控的洞察力. 2018;3(15):e120858.
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