CHMP Meeting Highlights May 2026 New
This month, medicinal products for the following indications have received a positive opinion:
- Temporary improvement of glabellar lines
- prevention of atherothrombotic events
- breast cancer
- Idiopathic Pulmonary Fibrosis
- Progressive Pulmonary Fibrosis
- PIK3CA-related overgrowth spectrum
New medicines recommended for approval:
Boey (trenibotulinumtoxinE): has received a positive opinion for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown (glabellar lines), when these have an important psychological impact in adult patients.
TrenibotulinumtoxinE is a neurotoxic protein produced by the bacterium Clostridium botulinum. It inhibits the release of the neurotransmitter acetylcholine and blocks the muscular contraction. Injection of Boey into the muscles under facial wrinkles causes relaxation of those muscles, resulting in the smoothing of the overlying skin. TrenibotulinumtoxinE has a shorter duration of effect than botulinum toxin A. For more information please consult the product for Boey on the EMA website.
Colchicine AGEPHA Pharma (colchicine): has received a positive opinion for secondary prevention of atherothrombotic events in adult patients with coronary disease stable for at least 6 months.
Colchicine is used in the treatment of acute gout attacks and in the prevention of gout flares. It is an anti-inflammatory medicinal product that inhibits microtubule polymerisation and modulates neutrophil activation. The mechanism of action in the prevention of cardiovascular effects are not fully understood. For more information please consult the product for Colchicine AGEPHA Pharma on the EMA website.
Etcamah (camizestrant): has received a positive opinion in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) 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.
Breast cancer is the leading cause of cancer and cancer deaths in women worldwide. Mutation in the ESR1 (estrogen receptor 1) gene are common acquired mutations that confer resistance to endocrine therapy. Etcamah is a Selective Estrogen Receptor Degrader (SERD). It binds to the estrogen receptor (ER) and cause it to be marked for destruction by the cell. By removing ER from the cell, SERDs block estrogen driven growth in ER positive breast cancers, even when the tumour has become resistant to other ER targeting drugs. For more information please consult the product for Etcamah on the EMA website.
Jascayd (nerandomilast): has received a positive opinion for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF) and for the treatment of adult patients with Progressive Pulmonary Fibrosis (PPF).
IPF and PPF are life threatening lung diseases in which the lung scares over time. The scar tissue (fibrosis) thickens and stiffens the lung tissue, impairing gas exchange and leading to shortness of breath, a dry cough, and eventually respiratory failure. Jascayd is a PDE4 inhibitor. This enzyme is expressed in the lungs and plays an important role in fibrosis and inflammation. By blocking it the disease progression is slowed.
A news announcement was released by the EMA for this product. For more information please consult the product for Jascayd on the EMA website.
Vijoice (alpelisib): has received a positive opinion for the treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.
PROS is a group of disorders caused by activating mutations in the PIK3CA gene, leading to tissue overgrowth and vascular anomalies. The severity of the disease ranges from localised tissue overgrowth to life-threatening malformations of organs. Alpelisib is an inhibitor of the PI3 kinase. It is already authorised for the treatment of metastatic breast cancer with a PIK3CA mutation.
An orphan designation was granted for the treatment of this disease and a news announcement was released by the EMA for this product. For more information please consult the product for Vijoice on the EMA website.
Recommendations on extensions of therapeutic indication:
Braftovi (encorafenib): extension of indication for Braftovi to include combination with cetuximab and FOLFOX the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.
Braftovi is already authorised for the treatment of colorectal cancer in a later line of therapy. For more information please consult the product for Braftovi on the EMA website.
Enhertu (trastuzumab deruxtecan): extension of indication for Enhertu to include the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options. Enhertu is already authorised for the treatment of breast, gastric and non-small cell lung cancer. For more information please consult the product for Enhertu on the EMA website.
Erbitux (cetuximab): extension of indication for Erbitux to include the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib in patients who have received prior systemic therapy.
It also received a positive opinion for the same treatment with addition of FOLFOX chemotherapy. Erbitux is already authorised for the treatment of colorectal cancer in different settings. For more information please consult the product for Erbitux on the EMA website.
Fasenra (benralizumab): extension of indication for Fasenra to include as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause. Fasenra is already authorised for the treatment of asthma and eosinophilic granulomatosis with polyangiitis. For more information please consult the product for Fasenra on the EMA website.
Hetronifly (serplulimab): extension of indication for Hetronifly to include in combination with carboplatin and nab-paclitaxel the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma. Hetronifly is already authorised for the treatment of non-small cell lung cancer in different settings. For more information please consult the product for Hetronifly on the EMA website.
Iclusig (ponatinib): extension of indication for Iclusig to include the treatment of paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is already authorised for the treatment of adult patients. For more information please consult the product for Iclusig on the EMA website.
Keytruda (pembrolizumab): extension of indication for Keytruda to include in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, the treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy. Keytruda also received a positive opinion for the inclusion of adolescents aged 12 years and older in three indications.
The indications are:
- KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.
- KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection.
- KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
For more information please consult the product for Keytruda on the EMA website.
Maviret (glecaprevir / pibrentasvir): extension of indication for Maviret to include the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.
Previously Maviret was only authorised for the treatment of chronic HCV infections. For more information please consult the product for Maviret on the EMA website.
Padcev (enfortumab vedotin): extension of indication for Padcev to include in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. Padcev is already authorised for the treatment of urothelial cancer. For more information please consult the product for Padcev on the EMA website.
Palynziq (pegvaliase): extension of indication for Palynzig to include the treatment of of patients with phenylketonuria (PKU) aged 12 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options. Previously the age limit was 16 years of age. For more information please consult the product for Palynziq on the EMA website.
Sogroya (somapacitan): extension of indication for Sogroya to include the treatment of Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later. Also received a positive opinion for the treatment of growth failure in children and adolescents with Noonan syndrome. For more information please consult the product for Sogroya on the EMA website.
Tepkinly (epcoritamab): extension of indication for Tepkinly to include in combination with lenalidomide and rituximab the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly is already authorised for the treatment of diffuse large B-cell lymphoma and follicular lymphoma after two or more lines of systemic therapy. For more information please consult the product for Tepkinly on the EMA website.
Trodelvy (sacituzumab govitecan): extension of indication for Trodelvy to include the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is already authorised for the treatment of HR-Positive, HER2-Negative breast cancer. For more information please consult the product for Trodelvy 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:
mCombriax: is indicated for active immunisation for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. EPAR mCombriax.
Ojemda: is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies. EPAR Ojemda.
Onerji: is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products. EPAR Onerji.
Palsonify: is indicated for the medical treatment of adult patients with acromegaly. EPAR Palsonify.
Rhapsido: is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1 antihistamine treatment. EPAR Rhapsido.
Xolremdi: is indicated in patients 12 years of age and older for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. EPAR Xolremdi.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
