Overview of CHMP October 2026 Meeting
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) convened from October 12 to 15, 2026, to review multiple applications for new medicines, biosimilars, and extensions of therapeutic indications. The committee issued positive opinions for six new medicines, recommended extensions for five existing medicines, confirmed a refusal for one medicine after re-examination, and noted withdrawals of two applications.
New Medicines Recommended for Approval
The CHMP recommended marketing authorisation for six medicines addressing a range of serious conditions:
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Rasonque (daraxonrasib): Indicated for adults with metastatic pancreatic adenocarcinoma who have undergone at least one prior treatment. This oral therapy was prioritized under EMA’s Cancer Medicines Pathfinder project due to the high unmet need in pancreatic cancer.
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Foundayo (orforglipron): An oral GLP-1 receptor agonist approved for weight management and treatment of type 2 diabetes in adults. Foundayo offers a once-daily tablet alternative to injectable GLP-1 therapies, potentially improving patient convenience and adherence.
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Yuviwel (navepegritide): Approved for treating achondroplasia in children, a genetic disorder caused by mutations in the fibroblast growth-factor receptor 3 gene that results in severely short stature and characteristic skeletal abnormalities.
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Fovlussea (ranibizumab biosimilar): A biosimilar for treating neovascular (wet) age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, and other retinal conditions causing visual impairment.
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Neuzafy (filgrastim biosimilar): Biosimilar indicated for neutropenia treatment in both adults and children, helping to reduce infection risk by stimulating white blood cell production.
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Kizfizo (temozolomide): A hybrid medicine for adults with glioblastoma multiforme and children with malignant glioma. The application combined data from an existing reference product with new clinical and pre-clinical data.
Extensions of Therapeutic Indications
The CHMP recommended extensions for five medicines already authorised in the European Union:
- Pandemic influenza vaccine H5N1 AstraZeneca
- Kyinsu
- Talvey
- Tryngolza
- Tukysa
These extensions aim to broaden the patient populations or conditions for which these medicines can be prescribed, enhancing treatment options.
Re-examination Outcome
Following a re-examination, the CHMP confirmed its initial recommendation to refuse marketing authorisation for Yartemlea (narsoplimab). This medicine was intended to treat haematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy, a serious complication after HSCT procedures. The refusal underscores the committee’s commitment to ensuring only medicines with robust evidence of safety and efficacy reach patients.
Withdrawn Applications
Two companies withdrew applications to extend indications for cancer medicines:
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Ibrance (palbociclib): Withdrawal of application for maintenance treatment in HR-positive, HER2-positive locally advanced or metastatic breast cancer.
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Truqap (capivasertib): Withdrawal of application for treatment of metastatic prostate cancer lacking PTEN protein.
These withdrawals may reflect strategic decisions based on emerging data or regulatory feedback.
Other Notable Updates
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The CHMP completed assessment of an application to extend Mylotarg (gemtuzumab ozogamicin) use to children aged 1 to less than 18 years with newly diagnosed acute myeloid leukaemia (AML). Although the extension was not recommended, the committee agreed to update the product information with relevant study data to inform healthcare professionals.
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The committee recommended changing the legal status of Nyxoid (naloxone) nasal spray to make it available without prescription. Nyxoid is used for emergency treatment of opioid overdose, facilitating wider access in critical situations.
Implications for Patients and Healthcare Providers
The CHMP’s positive opinions on new medicines like Rasonque and Foundayo represent significant advances in treating challenging conditions such as metastatic pancreatic cancer and type 2 diabetes. The approval of Yuviwel offers a novel therapeutic option for children with achondroplasia, addressing a rare genetic disorder with limited treatments.
Biosimilar approvals for Fovlussea and Neuzafy may enhance accessibility and reduce treatment costs for retinal diseases and neutropenia, respectively. The extension of indications for existing medicines broadens therapeutic choices, while the refusal and withdrawals highlight the rigorous standards maintained by the CHMP.
The reclassification of Nyxoid to non-prescription status could improve timely access to life-saving opioid overdose treatment, potentially reducing mortality.
Looking Ahead
The EMA will publish the minutes of the October 2026 CHMP meeting in the coming weeks, providing further details on the committee’s deliberations. Healthcare professionals and patients across Europe can anticipate the availability of these new and extended treatment options pending final European Commission decisions.
The CHMP’s ongoing evaluations reflect its pivotal role in ensuring that medicines authorised in the EU meet high standards of quality, safety, and efficacy, ultimately supporting public health and patient care.