This The news is for the Australian media only
- Eflornithin is now reimbursed by the government under Australia Pharmaceutical services diagram (PBS). The Advisory Committee on Society Benefits (PBAC) has recommended the list of eflonnithin for post-heart treatment in order to prevent relapse in patients with high-risk neuroblastoma (HRNB) who are in remission after receiving multi-imodial multi-emotional therapy.1
- About 50 children Australia A neuroblastoma is diagnosed each year, with almost half of half as having a high -risk neuroblastoma (HRNB). 3 These children have, on average, aged only 2 years, and the average survival rate for those with HRNB is 50%.2
Sydney,, August 1, 2025 / Prnewswire / – Norgine, announced today the inclusion of Ifinwil® (Eflornithin) on Australia Pharmaceutical services diagram (PBS). This list comes only 3 months after receiving registration by therapy administration of goods (TGA) and represents a pivotal step to improve access to essential treatments for patients with high-risk neuroblastoma (HRNB) who are in remission after receiving multi-element multimodality therapy.
Lucy JonesCEO Neuroblastoma Australiawelcomed the news: “On behalf of all the families of children affected by neuroblastoma, we welcome the PBS list of Ifinwil®. We need an emergency of treatment for children diagnosed with a neuroblastoma and this list guarantees that each child Australia has equal access to new therapy for this aggressive and complex cancer. Providing options to new treatments is essential to ensure that each diagnosed child has the best chances of survival. “”
“We thank the federal government for their support to ensure early access to this treatment before the TGA approval and the list of PBS, which has enabled children with high risk disease to access the treatment in a critical treatment window. We are impatiently awaiting continuous support for children with aggressive cancers.”
HRNB is a rare but aggressive form of cancer, mainly affecting children and most often presenting themselves in the first 5 years of life.2 Each year in AustraliaAbout 50 children receive a diagnosis of neuroblastoma, with about half of these cases being classified as high -risk neuroblastoma.3 Neuroblastoma comes from the body’s nerve cells (neuroblasts) and is generally presented as a primary tumor in the adrenal glands.4 It is considered an aggressive tumor because it often spreads to other parts of the body (metastases). In most cases, he has spread when he is diagnosed.4
“”Eflornithin (DFMO) is a new treatment for high -risk neuroblastoma, aggressive cancer seen mainly in infants and young childrensaid Doctor Toby TrahairPediatric oncologist at the Sydney children’s hospital. Having access to Eflornithin (DFMO) offers clinicians a well -necessary therapeutic option. It’s great to see that this new oral drug will be available for all Australian families via the PBS. “”
“”The PBS list of eflornithin is a historic moment for families affected by high -risk neuroblastoma in Australia“” said Gus RudolphGeneral manager, Australia in norgine. “This decision reflects the growing recognition of the urgent need of new treatment options in pediatric oncology. High -risk neuroblastoma has limited therapeutic and eflornithin therapeutic paths offers a new approach. We are grateful to the Australian government to have given clinicians access to this innovative therapy and we are committed to advancing solutions UNM. ” “”
Please refer to Ifinwil® Consumer medication information (CMI) For complete safety information on risks, side effects and precautions, including the risk of low red blood cells (anemia), low neutrophils (blood cells that fight against infection), low plates (coagulation cells), an increase in hepatic enzymes and balancing loss or hearing problems.
Parents should talk to their doctor to get advice on the best processing approach for their child.
Additional information on Ifinwil® (Eflornithin)
PBS information. Authority required. Section 100 highly specialized drug program. The restrictions apply. Please refer to the PBS program for more details.
Indication: For the treatment of adults and pediatric patients with high-risk neuroblastoma (HRNB) who responded to multi-eventual multi-event therapy.
Contraindications: Hypersensitivity to eflornithin or one of the excipients.
Special warnings and precautions: Myelosuppression, hepatotoxicity, hearing loss / hypoacusis, use in patients with kidney deficiency, the elderly and pediatric.
Interactions: No In vivo Drug interaction studies have been carried out with other drugs.
▼ This drug is subject to additional monitoring due to the approval of an extension of the indications. This will allow rapid identification of new security information. You can help by reporting the side effects you may get. You can report side effects to your doctor, or directly to www.tga.gov.au/reportting-problems.
Doctor Toby Trahair has sat on advisory advice and participated in symposiums sponsored by Norgine for which compensation has been received. With regard to this announcement of the norgine media, no compensation has been provided to Dr. Trahair, and the opinions expressed are his. Dr. Trahair was informed by Norgine about the approved use of this product.
Publisher notes
About Ifinwil®
Ifinwil® has been studied for use as a post-entretian treatment for high-risk neuroblastoma (HRNB) in pediatric patients after multi-agent multi-equality therapy.5 Ifinwil® is a therapy that blocks an enzyme called ornithin decarboxylase (ODC) responsible for the production of polyamines, which are important for tumor growth and development.6
For more information on Ifinwil®Find the public summary document here: Pharmaceutical services diagram (PBS) | Eflornithin; 192 mg tablet (like hydrochloride); Ifinwil® Or talk to your health professional.
Treatment context with high -risk neuroblastoma (HRNB)
Children diagnosed with HRNB undergo an intense treatment diet that always makes them vulnerable to relapse and death.7 Although there have been improvements in survival, the prognosis of children with high -risk neuroblastoma is still mediocre with around 80% of high -risk relapses occurring within 2 years from diagnosis, and long -term survival remains small, with only 15% of approximately 15% more than 5 years after rest.7.8.9 Avoid relapses is the key to long-term survival, and so far, there has been no approved therapy for the post-intrential treatment period on the main markets outside of The United States.10
About Norgine
Norgine has been a leading European specialized pharmaceutical company that has brought patients to patients for more than a century. Our commitment to transforming people’s lives motivates everything we do, and our European experience, a fully integrated infrastructure and an exceptional partnership approach allow us to quickly apply creative solutions to provide drugs that change their life to patients to whom they could not access otherwise. Norgine is proud to have helped more than 25 million patients worldwide in 2022 and generated 530 million euros in net products sales, growth of almost 5% compared to 2021.
Norgine has a direct presence in 16 European countries, as well as Australia And New Zealand. We also have a solid global network of partnerships on non -norgins markets. We are a flexible and fully integrated pharmaceutical company, with manufacturing (Hengoed, Wales and Dreux, France), third -party supply networks and significant product development capacity, in addition to our sales and marketing infrastructure. This allows us to acquire, develop and market specialized and innovative products that make a real difference in the lives of patients around the world.
Norgine and the SAIL logo are trademarks of the Norgine Group of Companies.
References
1 and 1 Australian public summary document: Pharmaceutical services diagram (PBS) | Eflornithin; 192 mg tablet (like hydrochloride); Ifinwil® . Accessed July 2025
2 https://www.neuroblastoma.org.au/about-key-statistics. Accessed July 2025
3 and 3 Anzchog-position-Stater-Eflornithin-DFMO-US-FORTOPTENTS-RIS-LAKE-NAINOBLASTOME-IN-Australia-And-Neo-Zeland-v2.0-23.08.2024.pdf. Accessed July 2025
4 https://rareseases.info.nih.gov/disases/7185/neuroblastoma. Accessed July 2025
5 Clinical trials NCT02395666; Preventive trial of difluornithinithin (DFMO) in high -risk patients with neuroblastoma which is in remission. Available on: Study details | Preventive trial of difluormornithin (DFMO) in high -risk patients with neuroblastoma which is in remission | Clinicaltrials.gov. Accessed July 2025
6. Meyskens fl Jr, Gerner EW. Development of the difluoromethydornithin (DFMO) as an agent of chemioprevention. CLAR CANCER RES. May 1999; 5 (5): 945-51
7 Basta no, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, et al. Factors associated with recurrence and survival length as a result of relapses in patients with neuroblastoma. BR J CANCER. 2016; 115: 1048-57.
8 Desai A, et al. Results following a post-consolidation treatment led by GD2 for neuroblastoma after cessation of a random assignment on Anbl0032: a report of the children’s oncology group. J Clin Oncol. 2022 Jul; JCO2102478.
9. London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, et al. Historical time for the progression of disease and progression -free survival in patients with a recurring / refractory neuroblastoma treated in the modern era on the early tent of children. Cancer. 2017; 123: 4914-23.
10 FDA approves eflornithin for adult and pediatric patients with high -risk neuroblastoma | The FDA FDA approves eflornithin for adult and pediatric patients with high -risk neuroblastoma | Fda. Accessed July 2025
Employment number:: UND-ONFW-2500008
Preparation date: July 2025
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