人用药品委员会（CHMP）2026年10月12-15日会议要点
正文 · 中文译文
欧洲药品管理局（EMA）的人用药品委员会（CHMP）在2026年10月的会议上建议批准六种药品。 Rasonque（daraxonrasib）获得CHMP的积极意见，用于治疗既往接受过至少一种治疗的成人转移性胰腺腺癌（已扩散的胰腺癌）患者。该建议是在对Rasonque数据进行分阶段审查后作出的，鉴于其满足这一未满足医疗需求的潜力，该药被认定为EMA癌症药物探路者项目下的高优先级药品。详见下方表格中的新闻公告。 委员会建议授予Foundayo（orforglipron）上市许可，这是一种口服GLP-1受体激动剂，用于成人体重管理和2型糖尿病的治疗。Foundayo将作为每日一次服用的片剂提供，为注射剂和其他口服GLP-1受体激动剂提供了替代选择。详见下方表格中的新闻公告。 CHMP建议授予Yuviwel（navepegritide）上市许可，用于治疗儿童软骨发育不全。软骨发育不全是一种由成纤维细胞生长因子受体3基因突变引起的遗传性疾病。该突变影响体内几乎所有骨骼的生长，包括颅骨、脊柱、手臂和腿部，导致身材非常矮小并具有特征性外观。 委员会对两种生物类似药采纳了积极意见： Fovlussea（雷珠单抗），用于治疗新生血管性（湿性）年龄相关性黄斑变性、糖尿病性黄斑水肿所致的视力损害、增殖性糖尿病视网膜病变、视网膜静脉阻塞继发黄斑水肿所致的视力损害以及脉络膜新生血管所致的视力损害。 Neuzafy（非格司亭），用于治疗成人和儿童的中性粒细胞减少症。 委员会建议授予Kizfizo（替莫唑胺）上市许可，用于治疗患有多形性胶质母细胞瘤（一种侵袭性脑肿瘤）的成人以及患有恶性胶质瘤（脑肿瘤）的儿童。该药品以混合申请方式提交，部分依赖于已授权参照药品的临床前试验和临床试验结果，部分依赖于新数据。 关于五种药品治疗适应证扩展的建议 委员会建议对五种已在欧盟（EU）获得授权的药品扩展适应证：大流行性流感疫苗H5N1 AstraZeneca、Kyinsu、Talvey、Tryngolza和Tukysa。 委员会在对其初步意见进行重新审查后，确认了其建议拒绝授予药品 Yartemlea（narsoplimab）上市许可的建议。该药品 intended for 治疗两岁及以上患有造血干细胞移植（HSCT）相关血栓性微血管病的成人和儿童。血栓性微血管病是 HSCT 后一种严重且可能危及生命的并发症，HSCT 是一种用供者的干细胞替换患者骨髓以形成产生健康细胞的新骨髓的手术。 更多信息，请参见下方表格中的问答文件。 两项扩大药品用途的申请已被撤回： Ibrance（palbociclib），一种用于治疗局部晚期或转移性乳腺癌的癌症药物。该公司撤回了将其用途扩大至 HR 阳性、HER2 阳性局部晚期或转移性乳腺癌成人患者维持治疗的申请。 Truqap（capivasertib），一种用于治疗激素治疗后复发或恶化的局部晚期或转移性乳腺癌的癌症药物。该公司撤回了将其用于治疗对激素治疗有反应且癌细胞缺乏一种名为 PTEN 的蛋白质的转移性前列腺癌的申请。 有关这两项申请撤回的问答文件可在下方表格中获取。 人用药品委员会（CHMP）已完成对Mylotarg（吉妥珠单抗奥唑米星）扩大适应症申请评估的定稿，该申请旨在将本品用于治疗年龄在1岁至18岁以下、新诊断患有急性髓系白血病（AML）的儿童患者。尽管委员会不建议批准该用途，但同意将申请所提交研究中的相关数据纳入该药品的产品信息中，以便医疗专业人员能够获取关于Mylotarg在这些患者中效应的最新数据。更多信息，请参见下方表格中的问答文件。 委员会建议更改Nyxoid（纳洛酮）的法律地位，使其无需医生处方即可获得。Nyxoid是一种鼻喷雾剂，用于已知或怀疑阿片类药物（如海洛因或吗啡）过量的紧急治疗。 2026年10月CHMP会议的议程已在欧洲药品管理局（EMA）网站上发布。会议纪要将在未来几周内公布。 2026年10月CHMP会议的主要数据如下图所示。 2026年10月统计数据——CHMP意见和撤回申请的月度及累计数据： 对新药发表6项积极意见：2种新的非罕见病药物、2种罕见病药物和2种生物类似药。2026年总计：72项 对新药发表0项否定意见。2026年总计：8项 对治疗适应症扩展发表5项积极意见。2026年总计：97项 2项新药申请被撤回。2026年总计：10项 治疗成人肥胖和2型糖尿病 用于体重管理和2型糖尿病的新型口服GLP-1药物 EMA建议批准Rasonque用于转移性胰腺癌 关于新生物类似药药物的积极建议 治疗新生血管性（湿性）年龄相关性黄斑变性（AMD）及成人其他视觉损害 治疗患有多形性胶质母细胞瘤的成人及患有恶性胶质瘤的儿童 关于治疗适应症扩展的积极建议 大流行性流感疫苗（H5N1）（减毒活疫苗，鼻用） 大流行性流感疫苗H5N1 AstraZeneca：待欧盟委员会决定 Tryngolza：待欧盟委员会决定（即将发布） 关于新药推荐复审的结果 撤回适应症扩展建议的申请 Truqap：问答（即将发布） 2026年9月由名称审查组（NRG）审查的（发明）名称概述——在2026年10月15日CHMP会议上通过 关于Mylotarg用于治疗儿童急性髓系白血病评估结果的问答 请注意，与本页面相关的文件并非同时发布。本页面在新文件可用时会尽快更新。因此，请用户定期查看本页面。 人用药品委员会（CHMP）：2026年10月12-15日 人用药品委员会（CHMP） 电话：+31 (0)88 781 8427 电子邮件：press@ema.europa.eu
正文 · 英文原文
EMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting. Rasonque (daraxonrasib) received a positive opinion from the CHMP for the treatment of adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have received at least one previous treatment. This recommendation follows a phased review of data on Rasonque, which was identified as a high-priority medicine under EMA’s Cancer Medicines Pathfinder project, given its potential to address this unmet medical need. See more details in the news announcement in the grid below. The committee recommended granting a marketing authorisation for Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and treatment of type 2 diabetes in adults. Foundayo will be available as a tablet taken once daily, providing an alternative to injectable and other oral GLP-1 receptor agonists. See more details in the news announcement in the grid below. The CHMP recommended granting a marketing authorisation for Yuviwel (navepegritide), for the treatment of achondroplasia in children. Achondroplasia is an inherited disease caused by a mutation in a gene called fibroblast growth-factor receptor 3. The mutation affects growth of almost all bones in the body including the skull, spine, arms and legs, resulting in very short stature with a characteristic appearance. The committee adopted positive opinions for two biosimilar medicines: Fovlussea (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation. Neuzafy (filgrastim), for the treatment of neutropenia in adults and children. The committee recommended granting a marketing authorisation for Kizfizo (temozolomide), for the treatment of adults with glioblastoma multiforme (an aggressive type of brain tumour) and children with malignant glioma (brain tumours). This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product, and in part on new data. Recommendations on extensions of therapeutic indication for five medicines The committee recommended extensions of indication for five medicines that are already authorised in the European Union (EU): Pandemic influenza vaccine H5N1 AstraZeneca , Kyinsu , Talvey , Tryngolza , and Tukysa . Following a re-examination of its initial opinion, the committee has confirmed its recommendation to refuse marketing authorisation for the medicine Yartemlea (narsoplimab). The medicine was intended for the treatment of adults and children from two years of age with haematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy. Thrombotic microangiopathy is a serious and potentially life-threatening complication following HSCT, a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow that produces healthy cells. For more information, see the question-and-answer document in the grid below. Applications to extend the use of two medicines were withdrawn: Ibrance (palbociclib), a cancer medicine used to treat breast cancer when the cancer is locally advanced or metastatic. The company withdrew its application to extend its use to the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer. Truqap (capivasertib), a cancer medicine used to treat breast cancer that is locally advanced or metastatic when the cancer has come back or worsened after hormonal treatment. The company withdrew its application for its use in the treatment of metastatic prostate cancer that responds to hormone treatment when the cancer cells lack a protein called PTEN. Question-and-answer documents on the withdrawal of these two applications are available in the grid below. The CHMP has finalised its assessment of an application to extend the use of Mylotarg (gemtuzumab ozogamicin) to include the treatment of children aged one to less than 18 years with newly diagnosed acute myeloid leukaemia (AML). Although the committee did not recommend this use, it agreed that relevant data from the study submitted with the application be included in the medicine’s product information so that healthcare professionals have access to-up-to date data on the effects of Mylotarg in these patients. For more information, see the question-and-answer document in the grid below. The committee recommended changing the legal status of Nyxoid (naloxone) to make it available without a medical prescription. Nyxoid is a nasal spray used for emergency treatment in case of known or suspected overdose of opioid drugs, such as heroin or morphine. The agenda of the October 2026 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks. Key figures from the October 2026 CHMP meeting are represented in the graphic below. October 2026 statistics - monthly and cumulative figures for CHMP opinions and withdrawn applications: 6 positive opinions on new medicines: 2 new non-orphan medicines, 2 orphan medicines, and 2 biosimilar medicine. Total in 2026: 72 0 negative opinions on new medicines. Total in 2026: 8 5 positive opinions on extensions of therapeutic indication. Total in 2026: 97 2 withdrawn application for new medicine. Total in 2026: 10 Treatment of obesity and type 2 diabetes mellitus in adults New oral GLP-1 medicine for weight management and type 2 diabetes EMA recommends authorisation of Rasonque for metastatic pancreatic cancer Positive recommendations on new biosimilar medicines Treatment of neovascular (wet) age-related macular degeneration (AMD), and other visual impairments in adults Treatment of adults with glioblastoma multiforme and children with malignant glioma Positive recommendations on extensions of therapeutic indications pandemic influenza vaccine (H5N1) (live attenuated, nasal) Pandemic influenza vaccine H5N1 AstraZeneca: pending EC decision Tryngolza: pending EC decision (to be published shortly) Outcome of re-examination on recommendation for new medicine Withdrawal of applications for recommendations on extensions of indications Truqap: questions and answers (to be published shortly) Overview of (invented) names reviewed in September 2026 by the Name Review Group (NRG) - Adopted at the CHMP meeting of 15 October 2026 Questions and answers on the outcome of assessment on use of Mylotarg in treatment of acute myeloid leukaemia in children Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly. Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2026 Committee for Medicinal Products for Human Use (CHMP) Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu