Phelinun

Oncology· 611 cited findings· 1 source document

Company: ADIENNE S.r.l.

What the regulatory reviews say

Phelinun is indicated in combination with other cytotoxic drugs as a reduced intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (HSCT) in adults with malignant haematological diseases. It is also indicated as a conditioning treatment prior to allogeneic HSCT in paediatric populations with haematological diseases. The marketing authorisation application for Phelinun was submitted on 11 March 2019, with a positive opinion for marketing authorisation issued on 17 September 2020.

Key efficacy findings include a 2-year overall survival (OS) of 62% for the FM regimen compared to 54% for the FB regimen. The 2-year leukemia-free survival (LFS) was 60% for the FM regimen versus 51% for the FB regimen. For high-risk disease, the 3-year OS rate for the FM140 group was 44.6%, compared to 34.8% for the FB2 group and 30.7% for the FB4 group.

Notable safety findings include an incidence of chronic GvHD ranging from 40-50% and hepatic sinusoidal obstruction syndrome (VOD) from 5-60%. Gonadal dysfunction was observed in 92% of men and 99% of women. Melphalan, a component of Phelinun, is genotoxic and carcinogenic, and associated with reproductive and developmental toxicity.

Key figures — cited to the source page

2-year overall survival (OS) for FM regimen	62	Phelinun EMA EPAR, p.37
2-year overall survival (OS) for FB regimen	54	Phelinun EMA EPAR, p.37
3-year OS rate for high-risk disease in FM140 group	44.6	Phelinun EMA EPAR, p.40
3-year OS rate for high-risk disease in FB2 group	34.8	Phelinun EMA EPAR, p.40
Incidence of chronic GvHD	40-50	Phelinun EMA EPAR, p.12
Incidence of gonadal dysfunction in women	99	Phelinun EMA EPAR, p.12
Date of positive opinion for marketing authorisation	17 September 2020	Phelinun EMA EPAR, p.8
Melphalan genotoxicity and carcinogenicity	genotoxic and carcinogenic	Phelinun EMA EPAR, p.24

Source documents

Unknown MAH — Phelinun EMA EPAR public assessment report (EMEA/H/C/005173, 2020) (2020)

Explore the full evidence

All 611 cited findings for Phelinun — searchable, comparable and answerable in plain language — are in the Oncology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.