CHMP Rejects Kizfizo for Neuroblastoma
Orphelia Pharma, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization 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. Orphelia will seek a re-examination of the opinion by the CHMP
“We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the pediatric oncology community as well as for parents of children suffering from cancer.” said Jérémy Bastid, Chief Medical Officer at Orphelia Pharma. “There is a significant demand for developing children-adapted formulations. Orphelia Pharma has been developing Kizfizo in collaboration with Gustave Roussy, the leading European cancer center, for the last seven years specifically to address this unmet medical need for a drinkable temozolomide medication in the treatment of relapsed or refractory neuroblastoma, which affects very young children”.
“As part of the re-examination process, we will seek to address the CHMP’s grounds for refusal and we will work diligently to substantiate the clinical benefit of the treatment so that Kizfizo can be available to pediatric patients in the EU without further delay” commented Laurent Martin, Chief Pharmaceutical Affairs Officer at Orphelia Pharma.
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