Norgine has announced that Swissmedic has approved the registration of IFINWIL (eflornithine) as a monotherapy for treating paediatric patients with high-risk neuroblastoma (HRNB) from one year of age.
The approval follows previous authorisations in the US, Israel, and Australia, marking a significant advancement in the availability of treatments for this aggressive form of cancer.
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Norgine vice-president and head of global regulatory affairs Jörg Plessl stated:“ 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 chief medical officer Dr David Gillen stated: “By collaborating with international regulatory partners through Project Orbis, we are advancing our strategy to broaden access to innovative therapies for paediatric patients in Europe and ANZ [Australia and New Zealand].
“At Norgine, we’re proud to take on some of the most complex disease areas, driven by our mission to deliver meaningful treatments where they’re needed most.”
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By GlobalDataHRNB is a rare yet aggressive cancer, primarily affecting children, particularly within the first five years of life. 10.2 per million under the age of 15 are diagnosed with neuroblastoma annually, with 50% high-risk cases. The condition frequently metastasises before diagnosis, and despite aggressive treatment, the five-year survival rate for HRNB is below 50%.
IFINWIL, which blocks the enzyme ornithine decarboxylase responsible for tumour growth, has been investigated as a post-maintenance treatment for HRNB in paediatric patients with no active disease or no evidence of disease after first-line therapy.
Project Orbis, an initiative of the US FDA Oncology Center of Excellence since May 2019, facilitates the concurrent submission and review of oncology products among international partners.
In April 2024, Norgine applied for the approval of eflornithine in HRNB through Project Orbis in Australia, Switzerland, and the UK. Subsequently, in April 2025, the Australian Therapeutic Goods Administration approved the registration of IFINWIL for adults and paediatric patients with HRNB who have responded to prior therapy.
