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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:
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.
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:
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
orforglipron
Eli Lilly Nederland B.V.
Treatment of obesity and type 2 diabetes mellitus in adults
daraxonrasib
Revolution Medicines Netherlands B.V.
Treatment of metastatic pancreatic cancer
navepegritide
Ascendis Pharma Growth Disorders A/S
Treatment of achondroplasia in children
This medicine was designated an orphan medicine.
ranibizumab
Accord Healthcare S.L.U.
Treatment of neovascular (wet) age-related macular degeneration (AMD), and other visual impairments in adults
filgrastim
CuraTeQ Biologics (Malta) Limited
Treatment of neutropenia in adults and children
temozolomide
Orphelia Pharma
Treatment of adults with glioblastoma multiforme and children with malignant glioma
This medicine was designated an orphan medicine.
insulin icodec / semaglutide
Novo Nordisk A/S
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
AstraZeneca AB
talquetamab
Janssen-Cilag International N.V.
This medicine was designated an orphan medicine.
olezarsen
Swedish Orphan Biovitrum AB (publ)
Tryngolza: pending EC decision (to be published shortly)
This medicine was designated an orphan medicine.
tucatinib
Pfizer Europe MA EEIG
narsoplimab
Omeros Ireland Limited
This medicine was designated an orphan medicine.
palbociclib
capivasertib
Truqap: questions and answers (to be published shortly)