Norgine欢迎澳大利亚 TGA注册 IFINWIL®（依氟鸟氨酸）用于被诊断为高风险神经母细胞瘤（HRNB）的成人和儿童-动脉网

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

CISION 等信源发布 2025-04-17 20:01



可切换为仅中文







IFINWIL

如果在野外

: now TGA registered in

: 现在TGA注册于

Australia

澳大利亚

Children diagnosed with neuroblastoma are on average just 2 years old

神经母细胞瘤患儿的平均年龄仅为2岁。

The average survival rate of children with HRNB is only 50%

高危神经母细胞瘤 (HRNB) 患儿的平均存活率仅为 50%。

UXBRIDGE,

England

英格兰

，

April 17, 2025

2025年4月17日

/PRNewswire/ --

Norgine

诺真

is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL

很高兴地宣布，澳大利亚治疗用品管理局 (TGA) 已批准 IFINWIL 的注册。

(eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy.

(依氟鸟氨酸) 用于治疗先前已对多药联合、多模式疗法产生应答的高危神经母细胞瘤 (HRNB) 成人和儿童患者。

Neuroblastoma

神经母细胞瘤

Australia

澳大利亚

welcomed the news today:

欢迎今天的消息：

On behalf of all families of children impacted by neuroblastoma, we welcome the TGA's decision to approve IFINWIL

代表所有受神经母细胞瘤影响的儿童家庭，我们欢迎TGA批准IFINWIL的决定。

. 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.' .

我们迫切需要为确诊神经母细胞瘤的儿童提供治疗，这一里程碑标志着我们在为儿童及其家庭创造更美好未来方面迈出了正确的一步。我们感谢联邦政府采取行动确保获取途径，并期待继续支持患有侵袭性癌症的儿童。

said

说

Lucy Jones

露西·琼斯

, CEO Neuroblastoma Australia.

，澳大利亚神经母细胞瘤首席执行官。

High Risk Neuroblastoma is a rare but aggressive form of cancer, predominantly affecting children and most commonly presenting in the first 5 years of life

高风险神经母细胞瘤是一种罕见但侵袭性很强的癌症，主要影响儿童，最常见于出生后的前5年。

. Each year in

. 每年在

Australia

澳大利亚

, approximately 50 children are diagnosed with neuroblastoma, with about half of these cases being classified as high risk neuroblastoma

大约有50名儿童被诊断出患有神经母细胞瘤，其中约一半的病例被归类为高风险神经母细胞瘤。

3,4

3，4

. Neuroblastoma originates in the body's nerve cells (neuroblasts) and typically presents as a primary tumour in the adrenal glands

神经母细胞瘤起源于身体的神经细胞（神经母细胞），通常表现为肾上腺的原发性肿瘤。

. 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 diagnosed

它被认为是一种侵袭性肿瘤，因为它经常扩散到身体的其他部位（转移）。在大多数情况下，它在被诊断时已经扩散。

。

'We are committed to improving the lives of children and their families living with high-risk neuroblastoma'

“我们致力于改善患有高风险神经母细胞瘤的儿童及其家庭的生活”

said

说

Gus Rudolph

古斯·鲁道夫

, General Manager, Norgine,

，总经理，Norgine，

Australia

澳大利亚

。

'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

“这种罕见的儿童癌症给受影响的人带来了毁灭性的后果，尽管还需要做更多的工作来改善治疗效果，但我们想对TGA迄今为止在此次审批中的工作表示认可。Norgine将继续与相关利益方合作，推动IFINWIL的进展。

to patients as quickly as possible.'

‘尽快提供给患者。’

'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,'

“作为Orbis项目倡议的一部分，此次批准代表了在确保世界各地患者获得创新癌症治疗方面迈出了重要一步。”

said Dr.

博士说。

David Gillen

大卫·吉伦

, Chief Medical Officer, Norgine.

，首席医疗官，诺瑞恩。

'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.'.

“通过与国际监管合作伙伴的协作，我们能够帮助将有前景的疗法更快地带给儿科患者——在时间紧迫的情况下，这一目标尤为重要。我们很自豪能支持Orbis项目，因为我们努力加快获得高影响力的肿瘤药物。”

Receiving the TGA approval is an important milestone on the path to realising sustainable and equitable access. IFINWIL

获得TGA批准是实现可持续和公平获取的重要里程碑。IFINWIL

is not currently included on the PBS.

当前未包含在PBS中。

Please refer to the

请参阅

IFINWIL

如果在威尔

Consumer Medicines Information (CMI)

消费者药品信息 (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.

有关风险、副作用和预防措施的完整安全信息，包括红细胞减少（贫血）、中性粒细胞减少（对抗感染的血细胞）、血小板减少（凝血细胞）、肝酶升高以及听力丧失或平衡问题的风险。

Notes to Editors:

编辑须知：

About IFINWIL

关于IFINWIL

IFINWIL

如果在威尔士

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.

已被研究用于高危神经母细胞瘤（HRNB）的维持治疗，适用于一线多药、多模式治疗后无活动性疾病（NAD）/无疾病证据（NED）的儿科患者。

IFINWIL

如果在野外

is a therapy that blocks an enzyme called ornithine decarboxylase (ODC) responsible for producing polyamines, which are important to tumour growth and development

是一种阻断鸟氨酸脱羧酶 (ODC) 的疗法，该酶负责产生对肿瘤生长和发展至关重要的多胺。

。

For more information on IFINWIL

有关 IFINWIL 的更多信息，请参阅

, find the CMI here:

，可以在这里找到CMI：

IFINWIL Consumer Medicine Information (CMI)

IFINWIL 消费者药品信息 (CMI)

or the Therapeutic Goods Administration at

或治疗用品管理局 tại

https://www.tga.gov.au/

or speak to your healthcare practitioner.

或咨询您的医疗保健医生。

High-Risk Neuroblastoma (HRNB) Treatment Background

高危神经母细胞瘤（HRNB）治疗背景

Children diagnosed with HRNB undergo an intense treatment regimen that still leaves them vulnerable to relapse and death.

被诊断为高危神经母细胞瘤的儿童会接受严格的治疗方案，但仍然容易复发和死亡。

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 survival

尽管生存率有所提高，但高危神经母细胞瘤患儿在维持治疗后的前5年内仍面临30%的复发（复燃）风险，且预后极差，长期生存的可能性很低。

(e.g. estimates as low as 15% of patients will live for five years after relapsing).

（例如，估计仅 15% 的患者在复发后能存活五年）。

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

避免复发是长期生存的关键，到目前为止，在主要市场之外的维持治疗后期尚无获批的疗法。

the United States

美国

。

About Project Orbis

关于Orbis项目

Project Orbis is an initiative (since

Project Orbis 是一项倡议（自

May 2019

2019年5月

) 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.

美国食品药品监督管理局（FDA）肿瘤学卓越中心（OCE）的一部分，并提供了一个框架，用于国际监管机构之间对创新肿瘤学产品的同步提交和协作审查。它的创建是为了加快全球患者获得创新癌症治疗的速度。

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), .

Project Orbis 由 FDA 协调，其合作伙伴包括英国药品和健康产品管理局 (UK MHRA)、澳大利亚治疗用品管理局 (TGA)。

Canada

加拿大

(Health Canada),

加拿大卫生部，

Singapore

新加坡

(Health Sciences Authority (HSA),

（健康科学局 (HSA)，

Switzerland

瑞士

(Swissmedic),

（瑞士医药管理局），

Brazil

巴西

(Agência Nacional de Vigilância Sanitária (ANVISA),

（巴西国家卫生监督局 (ANVISA)，

Israel

以色列

(Ministry of Health).

（卫生部）

在

April 2024

2024年4月

, Norgine submitted an application for approval of eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in

，Norgine通过Project Orbis提交了用于高风险神经母细胞瘤（HRNB）的依氟鸟氨酸的审批申请，在

Australia

澳大利亚

，

Switzerland

瑞士

and the

和

United Kingdom

英国

. This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology.

这一里程碑支持了Norgine为患者提供依氟鸟氨酸的可及性，并在儿科肿瘤领域带来更多的治疗选择。

About Norgine

关于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.

诺尔金是一家领先的欧洲专业制药公司，一个多世纪以来一直为患者带来变革性的药物。我们致力于改变人们生活的承诺驱动着我们的一切行动，我们在欧洲的经验、完全整合的基础设施以及卓越的合作方式使我们能够迅速应用创新解决方案，将改变生命的药物带给那些可能无法获得这些药物的患者。

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..

诺尔金自豪地宣布，2022年已帮助全球超过2500万名患者，实现净产品销售额5.3亿欧元，较2021年增长近5%。

Norgine has a direct presence in 16 European countries, as well as

诺尔金在16个欧洲国家以及

Australia

澳大利亚

and

和

New Zealand

新西兰

. 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,

我们在非Norgine市场也拥有强大的全球合作伙伴网络。我们是一家灵活且完全整合的制药企业，拥有生产设施（亨戈德，

Wales

威尔士

and Dreux,

和德勒，

France

法国

), 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.

此外，我们还拥有第三方供应网络和强大的产品开发能力，以及我们的销售和营销基础设施。这使我们能够获取、开发和商业化专业且创新的产品，这些产品对世界各地患者的生活产生真正的影响。

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

NORGINE 和帆船标志是 Norgine 集团公司的商标。

References

参考文献

Australian Product Information, IFINWIL

澳大利亚产品信息，IFINWIL

：

IFINWIL Product Information (PI)

IFINWIL 产品信息 (PI)

. Accessed

. 已访问

16.04.25

https://www.neuroblastoma.org.au/about-key-statistics

. Accessed

. 已访问

26.03.25

Australian Childhood Cancer Registry, Cancer Council Queensland. Australian Childhood Cancer Statistics Online (1983-2021). CCQ:

澳大利亚儿童癌症登记处，昆士兰癌症委员会。澳大利亚儿童癌症统计在线（1983-2021）。CCQ:

Brisbane, Australia

澳大利亚布里斯班

;

；

October 2024

2024年10月

。

ANZCHOG-Position-Statement-Eflornithine-DFMO-use-for-patients-with-high-risk-neuroblastoma-in-

ANZCHOG-立场声明-高风险神经母细胞瘤患者使用Eflornithine-DFMO-

Australia

澳大利亚

-and-

-和-

New-Zealand

新西兰

-v2.0-23.08.2024.pdf

-v2.0-2024年8月23日.pdf

https://rarediseases.info.nih.gov/diseases/7185/neuroblastoma

. Accessed

. 已访问

16.03.25

Clinical Trial NCT02395666; Preventative trial of difluoromethylornithine (DFMO) in high risk patients with neuroblastoma that is in remission. Available from:

临床试验 NCT02395666；二氟甲基鸟氨酸 (DFMO) 在缓解期的高风险神经母细胞瘤患者中的预防性试验。来源：

Study Details | Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission | ClinicalTrials.gov

研究详情 | 高风险神经母细胞瘤缓解期患者的二氟甲基鸟氨酸 (DFMO) 预防试验 | ClinicalTrials.gov

。

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梅斯肯斯 FL Jr，格纳 EW。

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临床癌症研究

. 1999 May;5(5):945-51. 4. Sholler GLS, et al. Sci Rep. 2018 Sep 27;8(1):14445.

1999年5月；5(5):945-51。4. Sholler GLS，等。《科学报告》。2018年9月27日；8(1):14445。

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.

巴斯塔 NO、霍尔迪 GC、马金 G、伯奇 J、费尔特鲍尔 R、布朗 N 等。神经母细胞瘤患者复发后与复发和生存期相关的因素。《英国癌症杂志》。2016年；115：1048-57。

Desai A, et al. J Clin Oncol. 2022 Jul; JCO2102478. 2. Lewis EC, et al. Int J Cancer. 2020 Dec;147(11):3152-3159

德赛 A 等。《临床肿瘤学杂志》。2022年7月；JCO2102478。刘易斯 EC 等。《国际癌症杂志》。2020年12月；147(11):3152-3159。

Bagatell R, DuBois SG, Naranjo A, et al. Children's Oncology Group's 2023 blueprint

Bagatell R, DuBois SG, Naranjo A, 等。儿童肿瘤组2023年蓝图

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.

London WB、Bagatell R、Weigel BJ、Fox E、Guo D、Van Ryn C 等。现代时期在儿童肿瘤学组早期临床试验中治疗的复发/难治性神经母细胞瘤患者的历史疾病进展时间和无进展生存期。《癌症》。2017年；123:4914-23。

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA

FDA 批准依氟鸟氨酸用于高危神经母细胞瘤的成人和儿童患者 | FDA

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | FDA

FDA 批准依氟鸟氨酸用于高危神经母细胞瘤的成人和儿童患者 | FDA

, Accessed

，访问

02.04.25

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