The Swiss Agency for Therapeutic Products (Swissmedic) has approved the use of Norgine’s IFINWIL (eflornithine) as a standalone treatment for children aged one year and older diagnosed with high-risk neuroblastoma (HRNB).
HRNB, a rare and aggressive cancer primarily affecting children under five, represents approximately 50% of neuroblastoma cases at the time of diagnosis. This cancer originates in nerve cells known as neuroblasts and frequently manifests as a tumour in the adrenal glands.
The disease is characterised by its propensity to metastasise rapidly.
Despite rigorous treatment protocols involving multiple therapies, the five-year survival rate for HRNB remains below 50%, contrasting starkly with over 95% for low-risk cases in infants. Neuroblastoma is responsible for roughly 15% of all deaths related to paediatric cancers, highlighting the critical need for innovative treatments.
IFINWIL has undergone investigation for its application as a post-maintenance therapy in HRNB patients who show no active or evident disease following initial multiagent, multimodality treatment. The drug functions by inhibiting ornithine decarboxylase (ODC), an enzyme facilitating the production of polyamines essential for tumour growth.
Norgine vice president and global regulatory affairs head Jörg Plessl said: “This milestone marks a further regulatory approval of IFINWIL for high-risk neuroblastoma, following approvals in the US, Israel and Australia.
“We deeply appreciate Swissmedic and the other Project Orbis partners for their keen awareness of the distinct challenges associated with paediatric oncology.
“Their agility in utilising adaptive regulatory pathways is crucial because the stakes are incredibly high when it comes to children’s lives. In these situations, speed and flexibility are not just advantageous, they can make all the difference.”
Norgine filed an application in April 2024 seeking the approval of eflornithine in high-risk neuroblastoma, via Project Orbis in Australia, Switzerland and the UK.
Project Orbis, initiated by the US FDA Oncology Center of Excellence in May 2019, facilitates the simultaneous submission and collaborative review of innovative oncology products by international regulatory bodies. Coordinated by the FDA, its partners include regulatory agencies from the UK, Australia, Canada, Singapore, Switzerland, Brazil, and Israel.
In April 2025, Norgine announced that the Australian Therapeutic Goods Administration authorised IFINWIL’s use for treating both adult and paediatric HRNB patients who have responded to prior multimodal therapies.
