Swissmedic, the Swiss agency responsible for the authorization and supervision of therapeutic products, has recently given the green light for a new treatment option that is set to change the landscape for children fighting high-risk neuroblastoma (HRNB). This approval of IFINWIL, also known as eflornithine, marks a significant milestone in the battle against this aggressive form of cancer that predominantly targets young children.
Neuroblastoma is a rare yet devastating cancer that strikes with ferocity, especially among children under five years old. The statistics paint a grim picture – approximately 10.2 out of every million children under 15 are diagnosed with neuroblastoma each year, with half classified as high-risk cases. This cruel disease often spreads rapidly before detection, and despite intensive treatments, the survival rate beyond five years remains distressingly low at less than 50%.
IFINWIL operates by inhibiting ornithine decarboxylase, an enzyme crucial for tumor development. It has emerged as a beacon of hope in the realm of post-maintenance therapies for HRNB patients who exhibit no active disease or signs of recurrence following initial treatment protocols.
In response to this groundbreaking development, Norgine’s Vice President and Head of Global Regulatory Affairs Jörg Plessl expressed gratitude towards Swissmedic and other partners involved in Project Orbis. Plessl highlighted the critical importance of swift regulatory actions in pediatric oncology:
“Their agility in utilising adaptive regulatory pathways is crucial because the stakes are incredibly high when it comes to children’s lives.”
Furthermore, Dr David Gillen, Chief Medical Officer at Norgine, emphasized their commitment to expanding access to cutting-edge treatments through collaborations like Project Orbis: “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.”
Project Orbis stands out as an initiative spearheaded by the US FDA Oncology Center of Excellence since May 2019. This platform streamlines the submission and assessment processes for oncology products across global jurisdictions. In April 2024, Norgine initiated efforts to secure eflornithine’s approval within Project Orbis frameworks in Australia, Switzerland, and the UK.
Subsequently gaining momentum on its regulatory journey in April 2025 was Australia’s Therapeutic Goods Administration which granted registration for IFINWIL not only for adult patients but also for pediatric cases grappling with HRNB who have shown positive responses to previous treatments.
The approval from Swissmedic further solidifies IFINWIL’s position as a beacon of hope amidst challenging circumstances faced by young patients battling neuroblastoma worldwide. As medical science continues its relentless pursuit towards conquering diseases like HRNB through innovative solutions like IFINWIL – every breakthrough brings us closer to brighter tomorrows filled with renewed hope and healing possibilities.
