news

Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]

Apr 17, 2025 · Source: cision
Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1]
  • IFINWIL®: now TGA registered in Australia
  • Children diagnosed with neuroblastoma are on average just 2 years old2
  • The average survival rate of children with HRNB is only 50%2

UXBRIDGE, England, April 17, 2025 -- Norgine is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL® (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy.1

Norgine Logo

Neuroblastoma Australia welcomed the news today:

"On behalf of all families of children impacted by neuroblastoma, we welcome the TGA's decision to approve IFINWIL®. We urgently need treatments for children diagnosed with neuroblastoma and this milestone marks a step in the right direction towards a better future for children and their families. We thank the Federal Government for taking action to ensure access and we look forward to continued support for children with aggressive cancers." said Lucy Jones, CEO Neuroblastoma Australia.

High Risk Neuroblastoma is a rare but aggressive form of cancer, predominantly affecting children and most commonly presenting in the first 5 years of life2. Each year in Australia, approximately 50 children are diagnosed with neuroblastoma, with about half of these cases being classified as high risk neuroblastoma3,4. Neuroblastoma originates in the body's nerve cells (neuroblasts) and typically presents as a primary tumour in the adrenal glands5. It is considered an aggressive tumour because it often spreads to other parts of the body (metastasizes). In most cases, it has spread by the time it is diagnosed5.

"We are committed to improving the lives of children and their families living with high-risk neuroblastoma" said Gus Rudolph, General Manager, Norgine, Australia. "This rare childhood cancer has devastating consequences for those impacted and while more needs to be done to improve treatment outcomes, we would like to recognise the TGA for their work to-date on this approval. Norgine will continue to engage with the relevant stakeholders to bring IFINWIL® to patients as quickly as possible."

"This approval, as part of the Project Orbis initiative, represents a vital step forward in ensuring access to innovative cancer treatments for patients around the world," said Dr. David Gillen, Chief Medical Officer, Norgine. "By working collaboratively with international regulatory partners, we are able to help bring promising therapies to paediatric patients sooner – a goal that is especially important when time is critical. We're proud to support Project Orbis as we strive to expedite access to high-impact oncology medicines."

Receiving the TGA approval is an important milestone on the path to realising sustainable and equitable access. IFINWIL® is not currently included on the PBS.

Please refer to the IFINWIL® Consumer Medicines Information (CMI) for full safety information on risks, side effects and precautions including the risk of low red blood cells (anaemia), low neutrophils (blood cells that fight infection), low platelets (clotting cells), increase in liver enzymes, and hearing loss or problems balancing.1

Notes to Editors:

About IFINWIL®

IFINWIL® has been investigated for use as a post maintenance treatment for high-risk neuroblastoma (HRNB) in paediatric patients with no active disease (NAD) / no evidence of disease (NED) after first line multiagent, multimodality therapy.6 IFINWIL® is a therapy that blocks an enzyme called ornithine decarboxylase (ODC) responsible for producing polyamines, which are important to tumour growth and development 7.

For more information on IFINWIL®, find the CMI here: IFINWIL Consumer Medicine Information (CMI) or the Therapeutic Goods Administration at https://www.tga.gov.au/ or speak to your healthcare practitioner.

High-Risk Neuroblastoma (HRNB) Treatment Background

Children diagnosed with HRNB undergo an intense treatment regimen that still leaves them vulnerable to relapse and death.8 Although there have been some improvements in survival, children with high risk neuroblastoma still face a 30% chance of recurrence (relapse) within the first 5 years post maintenance, and have an extremely poor prognosis and low likelihood of long term survival9 (e.g. estimates as low as 15% of patients will live for five years after relapsing).10 Avoiding relapse is key to long-term survival, and until now, there have been no approved therapies for the post maintenance treatment period in major markets outside of the United States11.

About Project Orbis

Project Orbis is an initiative (since May 2019) of the US FDA Oncology Center of Excellence (OCE) and provides a framework for concurrent submission and collaborative review of innovative oncology products among international regulatory authorities. It was created with the overarching goal to speed worldwide patient access to innovative cancer therapies. Project Orbis is coordinated by the FDA, and its partners include United Kingdom Medicines and Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods Administration (TGA), Canada (Health Canada), Singapore (Health Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of Health).

In April 2024, Norgine submitted an application for approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology.

About Norgine

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do, and our European experience, fully integrated infrastructure and exceptional partnership approach enable us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients around the world in 2022 and generated €530 million in net product sales, a growth of nearly 5% over 2021.

Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

References

  1. Australian Product Information, IFINWIL®: IFINWIL Product Information (PI). Accessed 16.04.25
  2. https://www.neuroblastoma.org.au/about-key-statistics. Accessed 26.03.25
  3. Australian Childhood Cancer Registry, Cancer Council Queensland. Australian Childhood Cancer Statistics Online (1983-2021). CCQ: Brisbane, Australia; October 2024.
  4. ANZCHOG-Position-Statement-Eflornithine-DFMO-use-for-patients-with-high-risk-neuroblastoma-in-Australia-and-New-Zealand-v2.0-23.08.2024.pdf
  5. https://rarediseases.info.nih.gov/diseases/7185/neuroblastoma. Accessed 16.03.25
  6. Clinical Trial NCT02395666; Preventative trial of difluoromethylornithine (DFMO) in high risk patients with neuroblastoma that is in remission. Available from: Study Details | Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission | ClinicalTrials.gov.
  7. Meyskens FL Jr, Gerner EW. Clin Cancer Res. 1999 May;5(5):945-51. 4. Sholler GLS, et al. Sci Rep. 2018 Sep 27;8(1):14445.
  8. Basta NO, Halliday GC, Makin G, Birch J, Feltbower R, Bown N, et al. Factors associated with recurrence and survival length following relapse in patients with neuroblastoma. Br J Cancer. 2016;115:1048-57.
  9. Desai A, et al. J Clin Oncol. 2022 Jul; JCO2102478. 2. Lewis EC, et al. Int J Cancer. 2020 Dec;147(11):3152-3159

    Bagatell R, DuBois SG, Naranjo A, et al. Children's Oncology Group's 2023 blueprint
  10. London WB, Bagatell R, Weigel BJ, Fox E, Guo D, Van Ryn C, et al. Historical time to disease progression and progression-free survival in patients with recurrent/refractory neuroblastoma treated in the modern era on Children's Oncology Group early-phase trials. Cancer. 2017;123:4914-23.
  11. FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA, Accessed 02.04.25

Logo - https://mma.prnewswire.com/media/597589/4648918/Norgine_Logo.jpg

 

 

Cision View original content:https://www.prnewswire.com/in/news-releases/norgine-welcomes-tga-registration-in-australia-of-ifinwil-eflornithine-for-adults-and-children-diagnosed-with-high-risk-neuroblastoma-hrnb1-302430920.html

Comments (0)

Login to join the conversation

Login / Register

No comments yet. Be the first to comment!

More to Read

Thrupp & Maberly: Historic British Coachbuilder Enters a New Era of Bespoke Motor Cars
news
Aug 7, 2026 1 min

Thrupp & Maberly: Historic British Coachbuilder Enters a New Era of Bespoke Motor Cars

COVENTRY, England , Aug. 7, 2026 -- One of Britain s most historic names in coachbuilding enters a new chapter. Thrupp & Maberly, whose origins trace back to the eighteenth century, returns as a contemporary British coachbuilding atelier dedicated to creating highly bespoke motor cars for a discerning international clientele. Based in Coventry, the company combines traditional craftsmanship with modern engineering, contemporary design, and uncompromising attention to detail.

HarperCollins Publishers to publish Dr Sylvia Karpagam's new book about the politics of food
news
Aug 7, 2026 1 min

HarperCollins Publishers to publish Dr Sylvia Karpagam's new book about the politics of food

The Meat of the Matter by Dr Sylvia Karpagam NEW DELHI , Aug. 7, 2026 -- HarperCollins India is delighted to be publish Dr Sylvia Karpagam s well-researched and path-breaking book which dives deep into the discourse around our food choices and the politics of nutrition which affects our well-being as a community. Available now to preorder, the book will release on 18 th August 2026. Talking about the book, Dr Sylvia Karpagam says, This book offers the basics of nutrition to help plan a meal in a scientific way without all the confusing jargon. It also explains the politics, economics, caste and communalism behind current nutrition policies, programs and interventions which are adversely affecting the nutritional and health indicators of the country, particularly for the marginalised and vulnerable who face barriers to accessing their own traditional foods. This is evident in the poor quality of the mid-day meal scheme in government schools and pre-schools (anganwadis) as also the Public Distribution System [PDS]. The global push for plant based /vegan foods by multi-nationals is creating a caste and corporate nexus that we need to challenge. This book offers a means to do that.

Lumina Datamatics Completes Acquisition of TNQTech, Creating a Global Leader in Scholarly Publishing Solutions
news
Aug 7, 2026 1 min

Lumina Datamatics Completes Acquisition of TNQTech, Creating a Global Leader in Scholarly Publishing Solutions

MUMBAI, India, Aug. 7, 2026 -- Lumina Datamatics, a global leader in content, retail support, and technology solutions, today announced the completion of its acquisition of TNQTech , a leading Chennai-based publishing technology company. This transaction marks a significant milestone in Lumina Datamatics organic and inorganic growth strategy and positions the combined organization among the world s largest providers of scholarly publishing solutions.

Office assets lead real estate investments across APAC and India in H1 2026, accounting for over 40% of total inflows in India: Colliers
news
Aug 7, 2026 1 min

Office assets lead real estate investments across APAC and India in H1 2026, accounting for over 40% of total inflows in India: Colliers

APAC investments reach USD 105 billion in H1 2026, the strongest first half since 2022 Capital deployment in office assets across APAC markets touch USD 40.2 billion during H1 2026 Capital remains focused on most liquid markets such as Australia, China, Japan & Singapore In India, investors are increasingly expanding beyond office assets into mixed-use developments & alternative assets GURUGRAM, India , Aug. 7, 2026 -- Asia Pacific s real estate market recorded its strongest first half since 2022, with investment activity reaching USD 105 billion in H1 2026 as cross-border capital returned and investors deployed capital across a broad mix of markets and sectors.

Solidion Technology Achieves Dramatic Balance Sheet Improvement, Increased Revenues
news
Aug 6, 2026 1 min

Solidion Technology Achieves Dramatic Balance Sheet Improvement, Increased Revenues

Private Placement Eliminates Balance Sheet Overhang and Alleviates Previously Disclosed Going Concern Doubt DALLAS , Aug. 6, 2026 -- Solidion Technology Inc. ( Solidion or the Company ) (Nasdaq: STI), an advanced battery technology solutions provider, today has released Second Quarter 2026 Financial and Operating Results. The condensed consolidated financial statements of Solidion and additional information can be found in Solidion s Form 10-Q, filed with the Securities and Exchange Commission, August 6, 2026 (the Form 10-Q ). This earnings release should be read together with the information contained in the Form 10-Q.

Seaspan Becomes First International Ship Owner and Operator to Access China's Panda Bond Market
news
Aug 6, 2026 1 min

Seaspan Becomes First International Ship Owner and Operator to Access China's Panda Bond Market

SINGAPORE , Aug. 6, 2026 -- Seaspan Corporation Pte. Ltd. ( Seaspan ), a leading independent maritime asset owner and operator, is pleased to announce the successful issuance of a RMB 1.5 billion Panda Bond in China s domestic bond market. The three-year private placement note was issued on July 15, 2026, with a coupon rate of 2.50% per annum. The offering was oversubscribed by Chinese onshore and international investors with a book coverage ratio of 2.3 times.

Cyble Says the Future of Endpoint Security Goes Beyond Detection, Unveils the Next Evolution of Titan at Black Hat USA 2026
news
Aug 6, 2026 1 min

Cyble Says the Future of Endpoint Security Goes Beyond Detection, Unveils the Next Evolution of Titan at Black Hat USA 2026

New release combines silicon-rooted attestation, AI-native threat intelligence, BlazeAI-powered attack reconstruction and autonomous response into a unified endpoint security platform for the AI era. LAS VEGAS , Aug. 6, 2026 -- Cyble today unveiled the next evolution of Cyble Titan at Black Hat USA 2026, introducing silicon-rooted attestation alongside AI-native threat intelligence, BlazeAI-powered attack reconstruction, exposure management and autonomous response in a unified endpoint security platform. Titan helps security teams establish trusted evidence, understand attacks faster and respond with greater confidence.

Cision Wins 2026 MarTech Breakthrough Awards for Social Listening, Press Release Distribution, and AEO
news
Aug 6, 2026 1 min

Cision Wins 2026 MarTech Breakthrough Awards for Social Listening, Press Release Distribution, and AEO

Brandwatch named Social Listening Solution of the Year, while PR Newswire secures top honors for Press Release Distribution Company of the Year and AEO Platform of the Year CHICAGO , Aug. 6, 2026 -- Cision, a global leader in consumer and media intelligence, today announced that two of its brands, Brandwatch and PR Newswire, have together earned three major category honors in the 2026 MarTech Breakthrough Awards.