Swissmedic Grants Approval for IFINWIL® to Treat Children with High-Risk Neuroblastoma

Introducing IFINWIL®: A New Hope for Children with High-Risk Neuroblastoma



In a significant advancement for pediatric oncology, Swissmedic has officially authorized the registration of IFINWIL® (eflornithine) as a monotherapy specifically designed for children aged one and up diagnosed with high-risk neuroblastoma (HRNB). This approval marks an important milestone for Norgine, a reputable European specialty pharmaceutical company, facilitating broadened access to innovative cancer therapies.

Understanding High-Risk Neuroblastoma (HRNB)



High-risk neuroblastoma is a rare yet aggressive form of cancer predominantly affecting children under five years of age. The condition emerges from neuroblasts, which are immature nerve cells that can develop into tumors, primarily located in the adrenal glands. Alarmingly, approximately ten children per million globally are diagnosed with neuroblastoma each year, and nearly half of these cases are identified as high-risk from the start.

Despite medical advancements, the prognosis for HRNB remains disheartening, with a five-year survival rate lingering around 50%. A staggering statistic reveals that neuroblastoma accounts for approximately 15% of all pediatric cancer deaths, further emphasizing the pressing need for effective therapeutic options.

The Role of IFINWIL® in Treatment



IFINWIL® aims to change the landscape of treatment for HRNB. Scientifically, it functions by inhibiting an enzyme known as ornithine decarboxylase (ODC), which plays a critical role in tumor growth and development by producing polyamines. Currently, the therapy is being explored as a post-maintenance solution for pediatric patients demonstrating no active disease after undergoing initial multiagent, multimodality therapy.

Historically, children receiving treatment for HRNB have questionable outcomes despite intensive regimens that include multiple therapies. High relapse rates, with approximately 80% occurring within two years of diagnosis, underscore the urgent need for novel treatment strategies. Until now, there have been no approved therapies designated for the post-maintenance treatment period in major markets outside of the United States.

Commitment to Pediatric Oncology



Jörg Plessl, Vice President and Head of Global Regulatory Affairs at Norgine, expressed profound gratitude towards Swissmedic and partners of the initiative termed Project Orbis, highlighting their progressive approach to pediatric oncology.

Topics Health)

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