CHMP Meeting Highlights October 2026 New
This month, medicinal products for the following indications have received a positive opinion:
- Weight management
- Type 2 diabetes mellitus
- Pancreatic cancer
- Brain tumour
- Achondroplasia
New medicines recommended for approval:
Foundayo (orforglipron): has received a positive opinion as an adjunct to healthy diet and physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
- ≥ 30 kg/m2 (obesity), or
- ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight- related comorbidity e.g. prediabetes or type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.
Foundayo also received a positive opinion for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to healthy diet and physical activity
- as monotherapy when metformin is considered inappropriate
- in combination with other medicinal products for the treatment of diabetes.
Type 2 diabetes mellitus is a metabolic disease characterised by high blood sugar and insulin resistance and it accounts for around 90% of diabetes cases. Although some people can have certain genetic predisposition, T2DM occurs primarily as a result of obesity and sedentary lifestyle. The prevalence of T2DM continues to increase globally along with obesity and overweight.
Foundayo is an oral glucagon-like peptide-1 (GLP-1) receptor agonist. By activating the GLP-1 receptors, Foundayo improves blood sugar control and decreases appetite. A news announcement was released by the EMA. For more information please consult the product for Foundayo on the EMA website.
Kizfizo (temozolomide): has received a positive opinion for the treatment of:
- adult patients with newly‑diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
- children from the age of one year, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Gliomas are neuroepithelial brain tumors that arise from glial cells in the central nervous system. They are among the most common malignant primary brain tumors. In addition to glioblastoma, the category of gliomas includes astrocytic, oligodendrocytic, and ependymal subtypes.
Kizfizo is hybrid medicinal product of Temodal (and generics), which is approved since 1999. It is a newly formulated oral suspension for the treatment of paediatric patients between 1 and 3 years of age. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Kizfizo on the EMA website.
Rasonque (daraxonrasib): has received a positive opinion for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
Ductal pancreatic adenocarcinoma is the most common form of exocrine pancreatic cancer and is characterized by an aggressive clinical course. In most patients, the disease is already at an advanced stage at the time of initial diagnosis; only about 15–20% of patients have a tumour that can be surgically removed at the time of diagnosis.
Rasonque is a novel RAS inhibitor that targets the active state of the RAS protein. Other already approved RAS inhibitors target individual alterations of RAS in the cancer cells. RAS proteins are involved in cell growth and survival, and most pancreatic adenocarcinoma have mutations in the RAS gene leading to a permanent activation of the RAS pathway. By inhibiting this pathway the cancer cells dies and the cancer growth is slowed. An orphan designation was granted for the treatment of this disease and news announcement was released by the EMA. For more information please consult the product for Rasonque on the EMA website.
Yuviwel (navepegritide): has received a positive opinion for the treatment of achondroplasia in children 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
Achondroplasia is a genetic disorder that causes a short stature, resulting from a mutation in the FGFR3 gene that disrupts normal bone growth. Individuals typically have short limbs, a normal-sized torso, and a slightly larger head. Other symptoms of the condition are musculoskeletal, neurological and respiratory complications.
Yuviwel is a prodrug of the C-type natriuretic peptide (CNP) a human peptide hormone. CNP binds to the natriuretic peptide receptor B and promotes chondrocyte differentiation and proliferation. This leads to increased bone growth. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Yuviwel on the EMA website.
Recommendations on extensions of therapeutic indication:
Kyinsu (insulin icodec / semaglutide): change of indication for Kyinsu to the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to oral antidiabetic medicinal products. Previously the patients had to be treated with basal insulin or a GLP-1 receptor agonist. For more information please consult the product for Kyinsu on the EMA website.
Pandemic influenza vaccine H5N1 AstraZeneca (pandemic influenza vaccine (H5N1) (live attenuated, nasal)): extension of indication to include the for active immunisation against influenza in an officially declared pandemic situation. Previously it was only authorised for the prophylaxis of influenza in paediatric patients between 1 and 18 years of age. For more information please consult the product for Pandemic influenza vaccine H5N1 AstraZeneca on the EMA website.
Talvey (talquetamab): extension of indication for Talvey to include in combination with daratumumab and pomalidomide or in combination with daratumumab the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior therapy. Talvey is already authorised as monotherapy for the treatment of relapsed or refractory multiple myeloma after 3 prior therapies. For more information please consult the product for Talvey on the EMA website.
Tryngolza (olezarsen): extension of indication for Tryngolza to include as an adjunct to diet, in combination with other lipid lowering therapies, for the treatment of adult patients with severe hypertriglyceridemia (sHTG, fasting triglyceride levels of ≥ 10 mmol/L (≥ 880 mg/dL)). Tryngolza is already authorised for the treatment of genetically confirmed familial chylomicronemia syndrome. For more information please consult the product for Tryngolza on the EMA website.
Tukysa (tucatinib): extension of indication for Tukysa to include in combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable or metastatic HER2-positive breast cancer following first-line chemotherapy. Tukysa is already authorised for the treatment of metastatic breast cancer in combination with trastuzumab and capecitabine after two prior therapies. For more information please consult the product for Tukysa on the EMA website.
Newly published EPARs:
The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:
Etcamah: in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor. In pre- or peri-menopausal women and in men, Etcamah plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist.
Nezglyal: Nezglyal is indicated for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non-Gadolinium (Gd) enhancing lesions (i.e. Gd negative) in brain Magnetic Resonance Imaging (MRI), with a Neurological Functional Score (NFS) of 0 or 1.
Susvimo: is indicated in adult patients for the treatment of neovascular (wet) age-related macular degeneration (nAMD) who have achieved stable disease after previously responding to intravitreal treatment with a vascular endothelial growth factor (VEGF) inhibitor medicinal product.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-meeting-highlights-basg
