EMA CHMP 10月例会：批准六项药物（含Revolution Medicines的daraxonrasib、礼来口服GLP-1 orforglipron），维持拒绝Omeros的narsoplimab，辉瑞/阿斯利康两项适应症扩展申请撤回

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.
Outcome of re-examination
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.
Withdrawal of applications
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.
Other updates
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.
Agenda and minutes
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.
CHMP statistics
Key figures from the October 2026 CHMP meeting are represented in the graphic below.
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.