CHMP Meeting Highlights January 2025 New
This month, medicinal products for the following indications have received a positive opinion:
- Breast cancer
- Cervical cancer
- Chikungunya vaccination
- Helminth infections
- Lymphatic filariasis
- Streptococcus pneumoniae vaccination
New medicines recommended for approval:
Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)): has received a positive opinion for the marketing authorization for the active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
Streptococcus pneumoniae is the most common identified pathogen in hospitalized pneumonia patients. Pneumonia is an infection of the lung and has a considerable morbidity rate in older adults or people with immune deficiency. For more information please consult the product for Capvaxive on the EMA website.
Datroway (datopotamab deruxtecan): has received a positive opinion for the marketing authorization for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
Breast cancer (BC) is the leading cause of cancer and cancer deaths in women worldwide, especially when diagnosed at an advanced stage. BC is categorised to subtypes according to its histopathology. Oestrogen receptor (ER) and progesterone receptor (PR) positive tumours are referred to as hormone-receptor (HR) positive BC. About 70% of all diagnosed BCs are HR positive and HER2 negative. For more information please consult the product for Datroway on the EMA website.
Ivermectin/Albendazole (ivermectin and albendazole): has received a positive opinion for the marketing authorization for the treatment of:
- Soil-transmitted helminth infections, caused by one or more of the following parasites: Hookworm (Ancylostoma duodenale, Necator americanus), Roundworm (Ascaris lumbricoides), Whipworm (Trichuris trichiura) and Strongyloides stercoralis.
- Proven or suspected microfilaraemia in patients with lymphatic filariasis caused by Wuchereria bancrofti
in adults, adolescents and children ≥ 5 years of age.
Lymphatic filariasis also known as elephantiasis is disease, which impairs the lymphatic system and leads to painfully enlarged body parts.
Ivermectin/Albendazole was part of the EU-Medicines for all (EU-M4all) and a separate news news was published by the EMA. For more information please consult the product for Ivermectin/Albendazol on the EMA website.
Tivdak (tisotumab vedotin): has received a positive opinion for the marketing authorization for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
Cervical cancer is a cancer of the cervix - the lower, narrow end of the uterus. It is globally the fourth most common cancer in women. For more information please consult the product for Tivdak on the EMA website.
Vimkunya (Chikungunya vaccine (recombinant, adsorbed)): has received a positive opinion for the marketing authorization for the active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older.
Chikungunya is a viral disease caused by the Chikungunya virus, which is transmitted to humans by infected mosquitoes. Symptoms include fever and severe joint pain, muscle pain, headache nausea and fatigue. Chikungunya is a debilitating disease and can lead to multiorgan failure in a small proportion of patients. A separate news was published by the EMA. For more information please consult the product for Vimkunya on the EMA website.
Recommendations on extensions of therapeutic indication:
Breyanzi (lisocabtagene maraleucel): extension of indication for Breyanzi to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Breyanzi is already authorized for the treatment of different types of B-cell lymphoma and follicular lymphoma grade 3B. For more information please consult the product for Breyanzi on the EMA website.
Imfinzi (durvalumab): extension of indication for Imfinzi to include as monotherapy the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Imfinzi is already authorized for the treatment of biliary tract cancer, hepatocellular carcinoma and endometrial cancer. For more information please consult the product for Imfinzi on the EMA website.
Opdivo (nivolumab): extension of indication for Opdivo to include in combination with ipilimumab the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
Opdivo is already authorized for the treatment of different other types of cancer. For more information please consult the product for Opdivo on the EMA website.
Ronapreve (casirivimab / imdevimab): extension of indication for Ronapreve to include children of 2 years and weighing at least 10 kg for the treatment of COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Ronapreve should be used in accordance with official recommendations where available and based on information on the activity of casirivimab and imdevimab against presently circulating viral variants.
Previously the age limit was 12 years. For more information please consult the product for Ronapreve on the EMA website.
Rxulti (brexpiprazole): extension of indication for Rxulti to include adolescents aged 13 years and older for the treatment of schizophrenia.
Rxulti is already authorized for the treatment of adults. For more information please consult the product for Rxulti on the EMA website.
Sivextro (tedizolid phosphate): extension of indication for Sivextro in tablet formulation to include adolescents and children weighing at least 35 kg for the treatment of acute bacterial skin and skin structure Infections.
For the powder formulation for infusion the age limit was reduced to birth, which was previously 12 years. For more information please consult the product for Sivextro on the EMA website.
Slenyto (melatonin): extension of indication for Slenyto to include the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
Slenyto is already authorized for the treatment of insomnia in children and adolescents with autism spectrum disorder. For more information please consult the product for Slenyto on the EMA website.
Yervoy (ipilimumab): extension of indication for Yervoy to include in combination with nivolumab the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
Yervoy is already authorized for the treatment of different other types of cancer. For more information please consult the product for Yervoy 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:
Alhemo: Alhemo is indicated for routine prophylaxis of bleeding in patients with:
- haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more.
- haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
Alhemo EPAR
Augtyro: AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).
AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and
- who have received a prior NTRK inhibitor, or
- have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted.
Augtyro EPAR
Fluad: Prophylaxis of influenza in adults 50 years of age and older. Fluad EPAR
Flucelvax: Prophylaxis of influenza in adults and children from 6 months of age. Flucelvax EPAR
Hympavzi: Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with:
- severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors, or
- severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.
Hympavzi EPAR
Recently started procedures:
- Aflibercept - EMEA/H/C/006438 treatment of age-related macular degeneration (AMD) and visual impairment
- Denosumab - EMEA/H/C/006526 treatment of osteoporosis and bone loss.
- Denosumab - EMEA/H/C/006534 prevention of skeletal related events with advanced malignancies.
Hydrocortisone - EMEA/H/C/005201, PUMA prevention of bronchopulmonary dysplasia in preterm infants born less than 28 weeks of gestation. - In vitro diagnostic medical device - EMEA/H/D/006590 detection of HLA-B*5701 allele, which is a predictor of hypersensitivity to abacavir, a drug used for treating HIV-1 infection.
- Lifileucel - EMEA/H/C/004741, ATMP treatment of unresectable or metastatic melanoma.
- Mirdametinib - EMEA/H/C/006460 treatment of neurofibromatosis type 1.
- Olezarsen - EMEA/H/C/006477 treatment of familial chylomicronemia syndrome.
- Pridopidine - EMEA/H/C/006261, Orphan treatment of Huntington's disease.
- Sebetralstat - EMEA/H/C/006211, Orphan treatment of hereditary angioedema (HAE) attacks in adult and adolescents aged 12 years and older.
- Zuranolone - EMEA/H/C/006488 the treatment of postpartum depression (PPD) in adults.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
