On 17 September 2020, the European Medicines Agency\u2019s (EMA\u2019s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation\u202ffor the\u202fmedicinal product melphalan (Phelinun), intended for the treatment of certain haematological and other cancers and as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in haematological diseases in adults and children. <\/p>\n
The applicant for this medicinal product\u202fis ADIENNE S.r.l. S.U. <\/p>\n
Phelinun will be available as 50-mg and 200-mg powder and solvent for concentrate for solution for infusion. The active substance\u202fof Phelinun is melphalan, an anti-neoplastic agent (ATC code: L01AA03) which prevents the separation and replication of DNA, thereby preventing cell replication. <\/p>\n
The benefits of Phelinun from published studies in adults and children include increased overall survival, diseasefree survival, eventfree survival and nonrelapse mortality. <\/p>\n
The most common side effects are myelosuppression and haematological toxicities, gastrointestinal toxicity and immune system disorders. Amenorrhoea, ovarian disorders and premature menopause were also commonly reported. Infections, acute and chronic graft-versus-host disease were reported as the major causes of morbidity and mortality in the allo-HSCT setting. <\/p>\n
Phelinun is a hybrid medicine\u202fof Alkeran which has been authorised in the EU since 1996. Phelinun contains the same active substance\u202fas Alkeran but is intended for an additional indication\u202fbased on published literature. <\/p>\n
Studies have demonstrated the satisfactory quality of Phelinun. Since Phelinun is administered intravenously and is 100% bioavailable, a bioequivalence study\u202fversus the reference product Alkeran was not required. <\/p>\n
The full indications\u202fare: <\/p>\n
High-dose of Phelinun used alone or in combination with other\u202fcytotoxic\u202fmedicinal products\u202fand\/or total body irradiation is indicated in the treatment of: <\/p>\n
multiple myeloma <\/p>\n<\/li>\n
malignant lymphoma (Hodgkin, non-Hodgkin lymphoma) <\/p>\n<\/li>\n
acute lymphoblastic and myeloblastic leukemia <\/p>\n<\/li>\n
childhood neuroblastoma <\/p>\n<\/li>\n
ovarian cancer <\/p>\n<\/li>\n<\/ul>\n
Phelinun\u202fin combination with other cytotoxic medicinal products\u202fis indicated as RIC treatment prior to allo-HSCT in malignant haematological diseases in adults. <\/p>\n
Phelinun\u202fin combination with other cytotoxic medicinal products\u202fis indicated as conditioning regimen prior to allo-HSCT in haematological diseases in the paediatric population as: <\/p>\n
Phelinun should be prescribed by physicians experienced in the treatment of cancer. <\/p>\n
Detailed recommendations for the use of this product will be described in the Summary of product characteristics, which will be published in the\u202fEuropean public assessment report and made available in all official European Union languages after the marketing authorisation\u202fhas been granted by the European Commission. <\/p>\n
Hybrid applications rely in part on the results of pre-clinical tests and\u202fclinical trials\u202ffor a reference product and in part on new data. <\/p>\n