Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026
16 October 2026
Six new medicines recommended for approval; another five medicines recommended for extension of their therapeutic indications
News
Human
Medicines
Six new medicines recommended for approval
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.
© European Medicines Agency
CHMP statistics: Text version
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
Positive recommendations on new medicines
Foundayo
International non-proprietary name (INN)
orforglipron
Marketing authorisation applicant
Eli Lilly Nederland B.V.
Therapeutic indication
Treatment of obesity and type 2 diabetes mellitus in adults
More information
Foundayo: pending EC decision
News announcement
New oral GLP-1 medicine for weight management and type 2 diabetes
Rasonque
INN
daraxonrasib
Marketing authorisation applicant
Revolution Medicines Netherlands B.V.
Therapeutic indication
Treatment of metastatic pancreatic cancer
More information
Rasonque: pending EC decision
News announcement
EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
Yuviwel
INN
navepegritide
Marketing authorisation applicant
Ascendis Pharma Growth Disorders A/S
Therapeutic indication
Treatment of achondroplasia in children
More information
Yuviwel: pending EC decision
Orphan designation
This medicine was designated an orphan medicine.
Positive recommendations on new biosimilar medicines
Fovlussea
INN
ranibizumab
Marketing authorisation applicant
Accord Healthcare S.L.U.
Therapeutic indication
Treatment of neovascular (wet) age-related macular degeneration (AMD), and other visual impairments in adults
More information
Fovlussea: pending EC decision
Neuzafy
INN
filgrastim
Marketing authorisation applicant
CuraTeQ Biologics (Malta) Limited
Therapeutic indication
Treatment of neutropenia in adults and children
More information
Neuzafy: pending EC decision
Positive recommendation on new hybrid medicine
Kizfizo
INN
temozolomide
Marketing authorisation applicant
Orphelia Pharma
Therapeutic indication
Treatment of adults with glioblastoma multiforme and children with malignant glioma
More information
Kizfizo: pending EC decision
Orphan designation
This medicine was designated an orphan medicine.
Positive recommendations on extensions of therapeutic indications
Kyinsu
INN
insulin icodec / semaglutide
Marketing authorisation holder
Novo Nordisk A/S
More information
Kyinsu: pending EC decision
Pandemic influenza vaccine H5N1 AstraZeneca
Common name
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Marketing authorisation holder
AstraZeneca AB
More information
Pandemic influenza vaccine H5N1 AstraZeneca: pending EC decision
Talvey
INN
talquetamab
Marketing authorisation holder
Janssen-Cilag International N.V.
More information
Talvey: pending EC decision
Orphan designation
This medicine was designated an orphan medicine.
Tryngolza
INN
olezarsen
Marketing authorisation holder
Swedish Orphan Biovitrum AB (publ)
More information
Tryngolza: pending EC decision (to be published shortly)
Orphan designation
This medicine was designated an orphan medicine.
Tukysa
INN
tucatinib
Marketing authorisation holder
Pfizer Europe MA EEIG
More information
Tukysa: pending EC decision
Outcome of re-examination on recommendation for new medicine
Yartemlea
INN
narsoplimab
Marketing authorisation applicant
Omeros Ireland Limited
Orphan designation
This medicine was designated an orphan medicine.
More information
Yartemlea: questions and answers
Withdrawal of applications for recommendations on extensions of indications
Ibrance
INN
palbociclib
More information
Ibrance: questions and answers
Truqap
INN
capivasertib
More information
Truqap: questions and answers (to be published shortly)
Other updates
Overview of (invented) names reviewed in September 2026 by the Name Review Group (NRG) - Adopted at the CHMP meeting of 15 October 2026
Adopted
Reference Number:
EMA/225331/2026
English (EN)
(179.67 KB - PDF)
First published:
16/10/2026
View
Questions and answers on the outcome of assessment on use of Mylotarg in treatment of acute myeloid leukaemia in children
Reference Number:
EMADOC-1700519818-3508571
English (EN)
(162.71 KB - PDF)
First published:
16/10/2026
View
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.
Related content
EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
New oral GLP-1 medicine for weight management and type 2 diabetes
Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2026
Committee for Medicinal Products for Human Use (CHMP)
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Related medicine information
Foundayo
Rasonque
Yuviwel
Fovlussea
Neuzafy
Kizfizo
Kyinsu
Talvey
Tukysa
Tryngolza
Yartemlea
Mylotarg
Truqap
Ibrance
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