PHELINUN (melphalan) - PHELINUN (melphalan) - Transplantation

Opinions on drugs - Posted on Mar 25 2025

Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for reimbursement only in “High-dose of PHELINUN used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:

multiple myeloma;
malignant lymphoma (Hodgkin, non-Hodgkin lymphoma);
acute lymphoblastic and myeloblastic leukaemia;
childhood neuroblastoma.

PHELINUN in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.

PHELINUN in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:

Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases;
RIC treatment in case of non-malignant haematological diseases.”

Unfavourable opinion for reimbursement in the other situations covered by the MA indication.

Clinical Benefit

Substantial	The Committee deems that the clinical benefit of PHELINUN 50 mg/10 ml and 200 mg/40 ml (melphalan) is substantial only in “High-dose of PHELINUN used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: multiple myeloma; malignant lymphoma (Hodgkin, non-Hodgkin lymphoma); acute lymphoblastic and myeloblastic leukaemia; childhood neuroblastoma.”
Low	The Committee deems that the clinical benefit of PHELINUN 50 mg/10 ml and 200 mg/40 ml (melphalan) is low only in the indication “PHELINUN in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults. PHELINUN in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as: Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases; RIC treatment in case of non-malignant haematological diseases.”
Insufficient	The Committee deems that the clinical benefit of PHELINUN 50 mg/10 ml and 200 mg/40 ml (melphalan) is insufficient in the treatment of ovarian cancer and mammary adenocarcinoma to justify public funding in view of the alternatives available in the other MA situations.

Clinical Added Value

no clinical added value	In the treatment of multiple myeloma, malignant lymphoma, acute lymphoblastic and myeloblastic leukaemia and childhood neuroblastoma, these proprietary medicinal products are hybrids that do not provide any clinical added value (CAV V) compared to the proprietary medicinal products containing melphalan already listed.
Not applicable