CHMP Meeting Highlights February 2025 New
This month, medicinal products for the following indications have received a positive opinion:
- Multiple myeloma
- Dystrophic epidermolysis bullosa
New medicines recommended for approval:
Lynozyfic (Linvoseltamab): has received a positive opinion for a conditional marketing authorisation (CMA) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MM is a type of blood cancer characterized by the malignant proliferation of plasma cells that consistently express the B-cell maturation antigen (BCMA). BCMA is not expressed in normal non-hematopoietic cells.
Lynozyfic is a bispecific antibody that targets CD3, present on the surface of T-cells, and BCMA. Lynozyfic binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with BCMA, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis. For more information please consult the product for Lynozyfic on the EMA website.
Vyjuvek (beremagene geperpavec): has received a positive opinion for the marketing authorization for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.
DEB is a rare disease caused by mutations in the collagen VII gene leading to decreased production or function of collagen VII. DEB causes the skin to be fragile and blister easily. Vyjiuvek is the first topical treatment for this condition and a separate news was published by the EMA.
An orphan designation was granted for the treatment of this condition. Vyjuvek is an advanced therapy medicinal product (ATMP) and the development was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support. For more information please consult the product for Vyjuvek on the EMA website.
Recommendations on extensions of therapeutic indication:
Abrysvo (respiratory syncytial virus vaccine (bivalent, recombinant): extension of indication for Abrysvo to include the active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).
The previous age limit was 60 years. Abrysvo also indicated for passive protection in infants from birth trough maternal immunisation during pregnancy. For more information please consult the product for Abrysvo on the EMA website.
Calquence (acalabrutinib): extension of indication for Calquence to include as monotherapy the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor. Calquence is already approved for the treatment of chronic lymphocytic leukaemia (CLL). For more information please consult the product for Calquence on the EMA website.
Columvi (glofitamab): extension of indication for Columvi to include in combination with gemcitabine and oxaliplatin the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT). Columvi is already approved for the treatment of adult patients with DLBCL as monotherapy after two or more lines of systemic therapy. For more information please consult the product for Columvi on the EMA website.
Darzalex (daratumumab): extension of indication for Darzalex to include in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. Darzalex is already approved the treatment of multiple myeloma in different settings. For more information please consult the product for Darzalex on the EMA website.
Enhertu (trastuzumab deruxtecan): extension of indication for Enhertu as monotherapy to include hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. Enhertu is already approved for the treatment of HER2-positive metastatic breast cancer. For more information please consult the product for Enhertu on the EMA website.
Fabhalta (iptacopan): extension of indication for Fabhalta to include the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated. Fabhalta is already approved for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. For more information please consult the product for Fabhalta on the EMA website.
Imfinzi (durvalumab): extension of indication for Imfinzi to include in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements. Imfinzi is already approved for different types of cancer. For more information please consult the product for Imfinzi on the EMA website.
Ixchiq (Chikungunya vaccine (live)): extension of indication for Ixchiq to include the active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. Previously the age limit was 18 years of age. For more information please consult the product for Ixchiq on the EMA website.
Jaypirca (pirtobrutinib): extension of indication for Jayprica to include as monotherapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) who have been previously treated with a BTK inhibitor. Jayprica is already approved for the treatment of mantle cell lymphoma (MCL). For more information please consult the product for Jaypirca on the EMA website.
Kaftrio (ivacaftor, tezacaftor, elexacaftor) and Kalydeco (ivacaftor): extension of indication for the combination use of both medicinal products for the treatment of cystic fibrosis for patients aged two years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Previously both medicinal products were approved for the treatment of cystic fibrosis with at least one F508del mutation in the CFTR gene. A separate news about this extension was released by the EMA. For more information please consult the product for Kaftrio on the EMA website.
Prevymis (letermovir): extension of indication for Prevymis to include the prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Prevymis also received a positive opinion for the extension of indication for the prophylaxis of CMV disease in CMV-seronegative adults and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-]. Previously Prevymis was only approved for adults. For more information please consult the product for Prevymis on the EMA website.
Rinvoq (upadacitinib): extension of indication for Rinvoq to include the treatment of giant cell arteritis in adult patients. Rinvoq is already approved for different autoimmune diseases like rheumatoid arthritis. For more information please consult the product for Rinvoq on the EMA website.
Stelara (ustekinumab): extension of indication for Stelara to include the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Stelara is already approved for treatment of active Crohn’s disease in adults. For more information please consult the product for Stelara on the EMA website.
Supemtek Tetra (influenza quadrivalent vaccine (rDNA)): extension of indication for Supemtek Tetra to include the active immunization for the prevention of influenza disease in adults and children from 9 years of age and older. Supemtek Tetra is already approved for adults. For more information please consult the product for Supemtek Tetra on the EMA website.
Tremfya (guselkumab): extension of indication for Tremfya to include the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment. Tremfya is already approved for the treatment of plaque psoriasis and psoriatic arthritis. For more information please consult the product for Tremfyaon 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:
Beyonttra: is indicated for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra EPAR.
Gohibic: is indicated for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)). Gohibic EPAR.
Hetronifly: in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Hetronifly EPAR.
Kavigale: is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments. Kavigale EPAR.
Korjuny: is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy. Korjuny EPAR.
Nemluvio:
- Atopic dermatitis (AD): Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy.
- Prurigo nodularis (PN): Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Siiltibcy: is indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. Siiltibcy EPAR.
