Posted by Michael Wonder on 05 Dec 2024
Orphelia Pharma provides update on the regulatory submission of Kizfizo with the EMA
18 November 2024 - Orphelia to seek re-examination following CHMP negative opinion for the treatment of relapsed or refractory high-risk neuroblastoma
Orphelia Pharma announced today that the CHMP of the EMA has adopted a negative opinion on the marketing authorisation application for Kizfizo (temozolomide oral suspension) for the treatment of patients with relapsed or refractory high risk neuroblastoma, because the CHMP considered that a positive benefit-risk balance has not been established at this stage.
