Gefitinib

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care LONDON, UK I July 05, 2024 I AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the FLAURA2 Phase III trial published in The New England Journal of Medicine . In the trial, Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months). PFS results from blinded independent central review (BICR) were consistent with the results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy (19.9 months) (HR 0.62; 95% CI 0.48-0.80; nominal p=0.0002). Results from a prespecified exploratory analysis of patients in the FLAURA2 trial with brain metastases at baseline showed Tagrisso plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to Tagrisso monotherapy (HR 0.58; 95% CI 0.33-1.01) as assessed by BICR. With two years of follow up, 74% of patients treated with Tagrisso plus chemotherapy had not experienced CNS disease progression or death versus 54% of patients treated with Tagrisso monotherapy. While the overall survival (OS) results remained immature at the second interim analysis (41% maturity), a trend towards an OS benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone (HR 0.75; 95% CI 0.57-0.97), as presented at the 2024 European Lung Cancer Congress. The trial continues to assess OS as a key secondary endpoint. David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology and principal investigator for the trial, said: “Today’s news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new 1st-line treatment option with osimertinib now in combination with chemotherapy. The FLAURA2 results build on the established efficacy of osimertinib monotherapy, showing a meaningful nine-month improvement in progression-free survival and offering physicians the option to tailor treatment to a patient’s specific needs.” Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy. This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.” The safety profile of Tagrisso plus chemotherapy was consistent with the established profiles of the individual medicines. Adverse event (AE) rates were higher in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. Discontinuation rates of Tagrisso due to AEs were 11% for Tagrisso plus chemotherapy and 6% for monotherapy. Tagrisso is approved as monotherapy in more than 110 countries including in the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. Tagrisso with the addition of chemotherapy is also approved in the US, China, Japan and several other countries for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC. Tagrisso is also currently under review with global regulatory authorities for patients with unresectable, Stage III EGFRm NSCLC based on the LAURA Phase III trial. Notes Lung cancer Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 5 Lung cancer is broadly split into NSCLC and small cell lung cancer. 3 Each year there are an estimated 2.4 million people diagnosed with lung cancer globally, with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer. 3,5-6 In Europe, more than 450,000 people are diagnosed with lung cancer each year. 1 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. 7-9 Additionally, the majority of patients with NSCLC are diagnosed with advanced disease. 4 Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells. 10 FLAURA2 FLAURA2 is a randomised, open-label, multi-centre, global Phase III trial in the 1st-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with Tagrisso 80mg once-daily oral tablets with the addition of chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5)) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks. The trial enrolled 557 patients in more than 150 centres across more than 20 countries, including in the US, Europe, South America and Asia. The primary endpoint is PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS. Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against CNS metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC. There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC. Tagrisso is the only targeted therapy to improve patient outcomes in early-stage disease in the ADAURA Phase III trial , locally advanced stages in the LAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial . As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial with results expected later this year and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial. The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso plus savolitinib, an oral, potent and highly selective MET TKI, as well as other potential new medicines. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . Contacts For details on how to contact the Investor Relations Team, please click here . For Media contacts, click here . References SOURCE: AstraZeneca

药械追踪 No.1 / 卫材AD药物乐意保正式在中国上市 日本卫材与其合作伙伴渤健（纳斯达克股票代码：BIIB）共同宣布，人源化抗可溶性聚集淀粉样蛋白-β（Aβ）单克隆抗体乐意保（仑卡奈单抗）正式在中国上市。该药品于2024年1月获得中国国家药品监督管理局批准用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨海默病轻度痴呆。 卫材预计，2024年中国约有1700万由阿尔茨海默病引起的轻度认知障碍和轻度痴呆的患者，随着老龄化加剧，预计这一数字还会增长。在美国，仑卡奈单抗的年治疗费用为26500美元，而中国的价格尚未披露。卫材将在中国销售该产品，并通过专业的医药代表提供信息服务工作，同时还将致力于打造一个独特的、线上线下相结合的早期阿尔茨海默病诊断和治疗路径。该公司将与商保公司、体检机构和养老机构等开展合作，广泛提供疾病宣传和预检机会，鼓励高风险人群及早到专科医院就诊。 ->点击阅读原文，解锁完整双语新闻 No.2 / 石药集团PD-1单抗恩舒幸获NMPA附条件批准 2024年7月1日，石药集团（1093.HK）宣布，旗下PD-1单抗恩朗苏拜单抗注射液（商品名：恩舒幸）提交的上市申请已获国家药监局（NMPA）附条件批准，用于治疗至少一线含铂方案化疗失败的PD-L1表达阳性的复发或转移性宫颈癌患者。 恩舒幸本次获批主要是基于一项关键II期临床试验，入组患者为既往接受过至少一线含铂方案化疗失败的PD-L1表达阳性的复发或转移性宫颈癌患者（其中36.5%既往接受了≥2线全身治疗）。结果显示，恩舒幸治疗晚期宫颈癌显著提高了客观缓解率（ORR），独立影像评估委员会评估的ORR达29%，包括2例完全缓解和29例部分缓解，中位缓解持续时间为16.6个月。恩舒幸整体安全性良好。 恩舒幸是石药集团开发的重组抗PD-1全人源单克隆抗体，属IgG4型单抗药物，按照治疗用生物制品1类新药申报。目前，恩舒幸加含铂化疗联合/不联合贝伐珠单抗用于一线治疗PD-L1阳性（CPS≥1）的复发或转移性宫颈癌患者的III期临床试验正在开展。 ->点击阅读原文，解锁完整双语新闻 No.3 / 舒泰神血友病治疗药STSP-0601获美国 FDA 孤儿药资格 2024年7月1日，舒泰神（300204.SZ）宣布，bemiltenase alfa（STSP-0601）用于治疗 A 型血友病和 B 型血友病适应证获得美国FDA授予的孤儿药资格认定。 血友病是一种 X 染色体连锁的隐性遗传性出血性疾病，其遗传特点是男性发病，女性携带。血友病可分为血友病 A 和血友病 B，前者表现为凝血因子Ⅷ（FⅧ）缺乏，后者表现为凝血因子Ⅸ（FⅨ）缺乏。 注射用 STSP-0601 是国家 1 类治疗用生物制品。STSP-0601已完成用于“伴抑制物的血友病 A 或 B 患者出血按需治疗”的 I 期临床试验（登记号：CTR20191930），安全性和耐受性良好；STSP-0601用于“伴抑制物的血友病 A 或 B患者出血按需治疗”适应证的Ib/II 期临床试验（登记号：CTR20211762）和“不伴抑制物的血友病 A 或 B 患者出血按需治疗”的II 期临床试验均已取得总结报告。2022 年 09 月，STSP-0601被NMPA纳入突破性治疗品种名单。 ->点击阅读原文，解锁完整双语新闻 No.4 / 誉衡生物引进CXCR4多肽药物落地博鳌 2024年7月1日，誉衡生物宣布其核心产品创新细胞驱动因子受体CXCR4拮抗剂莫替福肽Motixafortide（国际商品名APHEXDA ，BL-8040）近日经海南省药品监督管理局批准，获得临床急需特许药品进口批件，博鳌鲁医医院即将启用。 莫替福肽是全球首款靶向CXCR4的多肽药物，于2023年9月获美国FDA批准上市，为15年来FDA唯一批准用于多发性骨髓瘤（MM）的创新干细胞动员剂。2023年誉衡生物与BiolineRx达成授权协议，取得莫替福肽所有适应证在亚洲地区的开发、生产和商业化权力。2024年5月基于获得上市批准的全球多中心临床Ⅲ期GENESIS研究中亚洲受试者数据预期无种族差异，誉衡生物获得国家药品监督管理局药品审评中心批准，开展一项在多发性骨髓瘤患者中联合粒细胞集落刺激因子（G-CSF）动员造血干细胞用于自体移植的桥接Ⅲ期临床研究。并于同期启动中国澳门及新加坡等地区的新药上市注册申请。 ->点击阅读原文，解锁完整双语新闻 企业动态 No.1 / 海森生物收购Celltrion 14款产品多地权益，开启泛亚太商业化布局 近日，海森生物宣布正式完成对韩国生物制药企业Celltrion旗下14种品牌产品在亚太多个国家和地区商业权益的收购，并拥有这些产品在包括韩国、新加坡、泰国、澳大利亚、中国香港等8个国家及地区的药品上市许可持有人（MAH）权益。本次收购将丰富海森生物在中国大陆地区以外的8个国家和地区的产品管线，并将建立更完善的国际化供应链及质量管理体系，更标志着海森生物正式开启泛亚太商业化布局。 收购完成后，海森生物将拥有高血压及糖尿病等慢性病领域多个经典产品如易达比、倍欣、艾可拓、必洛斯和尼欣那等在上述亚太8个国家和地区的商业化权益，并将以更丰富的产品组合惠及更多患者。作为一家聚焦慢性病及急重症领域的创新生物医药企业，海森生物将通过本次收购进一步加强公司在慢病生态系统的影响力。 ->点击阅读原文，解锁完整双语新闻 No.2 / 招商信诺与美国克利夫兰医学中心达成第二诊疗服务合作 近日，招商信诺及其健康管理子公司宣布与全球著名的美国克利夫兰医学中心达成战略合作，双方将聚焦中国重疾患者的海外就医和二次诊疗需求，依托美国克利夫兰医学中心丰富的医疗资源和专业的第二诊疗意见服务，助力医疗诊断准确性的提升和治疗方案的有效实施。 在现代医疗体系中，第二诊疗意见常被视为一个重要的安全"防火墙"，能够保护患者免受医疗误判和不当治疗方案的影响，尤其是病情复杂多变的重疾患者，迫切需要高度专业化的治疗计划以及跨学科的专业评估。基于此，招商信诺联合美国克利夫兰医学中心推出的"直通克利夫兰"第二诊疗服务涵盖了120种重大疾病，该服务依托美国克利夫兰医学中心在心脏、泌尿外科、肺病、肾病等领域积累的深厚专科底蕴，可通过多学科会诊（MDT）的方式，为患者提供多位专家的综合诊断与治疗建议。 ->点击阅读原文，解锁完整双语新闻 No.3 / 卫宁健康与联通数智医疗达成产品服务商业化创新合作 近日，卫宁健康与联通数智医疗科技有限公司在上海卫宁健康总部签署战略合作协议。双方将发挥各自在医疗卫生领域的优势，共同增强产品创新、服务创新、商业创新能力。 此次战略合作双方强强联手，将从行业解决方案融合、客户项目合作营销、技术应用研究、品牌推广等方面明晰合作路径。通过成立联合解决方案工作组，打造“智慧医院”、“数字医共体”等医卫行业解决方案，并依托联通“云网数智安”等平台资源与卫宁健康区域卫生、基层医疗、智慧医院等WiNEX系列软件产品体系适配，搭建整合营销方案加速项目获取和落地。在技术创新层面，计划建立智慧医疗联合实验室，开展信创平台、人工智能大模型开发与应用、云计算等前沿技术研究。 ->点击阅读原文，解锁完整双语新闻 No.4 / 利洁时斥资3亿元在上海设立全球研发中心 据报道，英国消费者健康和卫生产品制造商利洁时（RKT：XLON）将投资3亿元人民币（4170万美元）在上海漕河泾科技绿洲园区建立一个新的全球研发中心。该中心将占地8000平方米，预计将于2026年投入运营。届时将支持包括杜蕾斯、滴露、益节、亮碟等在内的所有利洁时品牌在中国的发展。 利洁时首席执行官李开睿表示，上海是科技创新中心，也是利洁时在中国发展的重心。他希望，通过深化科研合作和能力，培养发展本地人才，将进一步增强利洁时的业务，为中国消费者带来更多突破性的中国首发新品。 ->点击阅读原文，解锁完整双语新闻 行业政策 No.1 / 医保局发布2024国谈工作规则和申报指南 2024年6月28日，国家医保局发布《2024年国家基本医疗保险、工伤保险和生育保险药品目录调整工作方案》及申报指南等文件，规则与2023年相比基本相同。在往年经验做法的基础上，今年对《工作方案》进行了小幅调整。主要包括以下三方面： 一是按规则对药品获批和修改适应证的时间要求进行了顺延，2019年1月1日以后获批上市或修改适应证的药品可以提出申报。 二是调出品种的范围，将近3年未向医保定点医药机构供应的常规目录药品，以及未按协议约定保障市场供应的谈判药品列为重点考虑的情形，强化供应保障管理。 三是强化专家监督管理。为稳定企业预期，今年的续约规则和竞价规则与往年基本保持一致。 按照数据，2016年谈判新增的药品理论上符合8年常规准入标准，然而替诺福韦二吡呋酯和吉非替尼已于2017年进入常规目录管理，埃克替尼曾于2017年进入常规准入，但2021年重新启动谈判并于2023年新增适应证，今年也不符合8年常规准入条件。明年预计有9款2017年新增西药（假设无仿制药获批，不新增适应证）会符合这一条件。 ->点击阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻