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  1. EMA · What's New

    EMA将多发性骨髓瘤药teclistamab(Tecvayli)的条件性上市许可转为标准许可(EPAR第11版)

    EMA更新teclistamab(Tecvayli)的EPAR:该药用于复发或难治性多发性骨髓瘤成人患者,2022年8月23日获欧盟条件性上市许可,2026年8月20日因公司提交额外数据转为标准上市许可。

    关注理由:该EPAR第11版记录teclistamab由条件性上市许可转为标准许可这一监管证据升级,并汇总其单药及联合daratumumab研究的疗效与安全性数据,便于跟踪多发性骨髓瘤后续监管动作。

  2. EMA · What's New

    EMA通报止吐药Emend(aprepitant)欧盟/EEA供应短缺,Merck Sharp & Dohme B.V.因商业原因计划2028年5月前永久停市

    EMA通报Merck Sharp & Dohme B.V.因商业原因永久停市止吐药Emend(aprepitant,80 mg与125 mg规格),欧盟/EEA短缺持续,预计2028年5月前在所有国家停市,停市与产品质量缺陷或安全问题无关。

    关注理由:该通告确认aprepitant停市源于商业原因而非质量或安全问题,6月龄及以上儿童所需口服混悬剂型无替代品,是化疗支持用药供应需持续跟踪的关键缺口。

  1. ClinicalTrials.gov API v2 · 登记更新

    肿瘤学:Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

    原文摘录:This phase I/II trial studies the side effects and the best dose of selumetinib and how well it works in treating or re-treating young patients with low grade glioma that has come back (recurrent) or does not respond to treatment (refractory).

    关注理由:这条肿瘤学内容涉及相关临床或研究问题,建议查看原文中的方法与适用范围。

  1. EMA · Withdrawn Applications

    肿瘤学:Withdrawn application: Ibrance, 15/10/2026

    原文摘录:Ibrance - withdrawal of application for variation to marketing authorisation Application withdrawn The application for a change to this medicine's authorisation has been withdrawn palbociclib Post-authorisation Human Overview Pfizer Europe MA EEIG withdre … News on Ibrance Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026 16/10/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected) 21/09/2016 New treatment for breast cancer 16/09/2016 More information on Ibrance Ibrance This page was last updated on 28/10/2026

    关注理由:这篇肿瘤学内容涉及临床试验,适合了解研究正在回答什么问题,试验阶段和主要终点需以原文为准。

  1. EMA · News and Safety Reviews

    肿瘤学:EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

    原文摘录:Image credit: © Chinnapong | stock.adobe.com EMA recommends authorisation of Rasonque for metastatic pancreatic cancer 15 October 2026 Phased review fast tracks assessment of medicine addressing unmet medical need News Human Innovation Medicines EMA’s hum … eu All other enquiries Please submit your request via the online form Follow us on Bluesky Related medicine information Rasonque

    关注理由:这条肿瘤学内容涉及相关临床或研究问题,建议查看原文中的方法与适用范围。

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