FYARRO凭借强劲的增长前景在罕见肿瘤市场树立了新标准-动脉网

FYARRO Sets New Standard in Rare Oncology Market with Strong Growth Prospects

CISION 等信源发布 2025-04-18 05:31

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FYARRO holds strong market potential, particularly in treating rare and aggressive cancers like PEComa, where treatment options are limited. As the first FDA-approved therapy for advanced PEComa, it addresses a critical unmet need.

FYARRO具有强大的市场潜力，特别是在治疗像PEComa这类罕见且侵袭性的癌症方面，当前的治疗选择非常有限。作为首个获FDA批准用于晚期PEComa的疗法，它满足了关键的未满足需求。

LAS VEGAS

拉斯维加斯

，

April 17, 2025

2025年4月17日

/PRNewswire/ -- DelveInsight's '

/PRNewswire/ -- DelveInsight的'

FYARRO Market Size, Forecast, and Market Insight Report

FYARRO市场规模、预测和市场洞察报告

' highlights the details around FYARRO, an mTOR inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FYARRO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [

“强调了FYARRO（一种mTOR抑制剂）的详细信息。报告提供了FYARRO的产品描述、专利细节以及竞争对手的产品（已上市和新兴疗法）。报告还重点介绍了2020年至2034年期间按7MM分段的历史和预测销售额。

the United States

美国

, the EU4 (

，欧盟4（

Germany

德国

，

France

法国

，

Italy

意大利

, and

，以及

Spain

西班牙

), the

），这个

United Kingdom

英国

, and

，以及

Japan

日本

Whitehawk Therapeutics' FYARRO (sirolimus protein-bound/ABI-009) Overview

白鹰治疗公司的FYARRO（西罗莫司蛋白结合/ABI-009）概述

FYARRO (albumin-bound) is a targeted therapy approved for the treatment of adults with locally advanced unresectable or metastatic malignant PEComa. This medication is specifically designed to combat cancer by targeting abnormal growth signals in perivascular epithelioid cells, which multiply uncontrollably in advanced PEComa.

FYARRO（白蛋白结合型）是一种靶向治疗药物，获批用于治疗局部晚期不可切除或转移性恶性PEComa成人患者。该药物通过靶向血管周围上皮样细胞中的异常生长信号来对抗癌症，这些细胞在晚期PEComa中会不受控制地增殖。

By blocking a key pathway involved in tumor growth, FYARRO helps slow or stop the spread of cancer. Unlike traditional chemotherapy, FYARRO functions as a precision therapy..

通过阻断参与肿瘤生长的关键通路，FYARRO有助于减缓或阻止癌症的扩散。与传统化疗不同，FYARRO是一种精准治疗药物。

What sets FYARRO apart from other mTOR inhibitors is its use of nanoparticle technology, which enhances drug delivery directly into tumors. This allows for a more effective shutdown of the mTOR signaling pathways that drive cancer progression.

FYARRO 与其他 mTOR 抑制剂的不同之处在于它使用了纳米粒子技术，这种技术可以增强药物直接递送到肿瘤的效果。这使得关闭驱动癌症进展的 mTOR 信号通路更加有效。

FYARRO became commercially available in

FYARRO 商业化上市

the United States

美国

在

February 2022

2022年2月

. As per the company's SEC filing for the quarter ending

。根据公司截至季度末的SEC文件

September 30, 2024

2024年9月30日

, net product sales reached

，净产品销售额达到

USD 7.2 million

720万美元

for the three months and

三个月期间

USD 18.7 million

1870万美元

over the nine months. In comparison, during the same periods in 2023, sales were

在九个月期间。相比之下，在2023年的相同时期，销售额为

USD 6 million

600万美元

and

和

USD 18 million

1800万美元

, respectively. The year-over-year growth in both the quarterly and year-to-date figures for 2024 was mainly driven by robust market demand.

，分别。2024年季度和年初至今的数据的同比增长主要受到强劲市场需求的推动。

In addition to its role in treating PEComa, AADI Biosciences is also evaluating FYARRO in two Phase II clinical trials for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs). While new patient enrollment has been paused by the company, dosing continues for previously enrolled patients, with the studies set to provide initial efficacy signals in the coming months.

除了在治疗PEComa中的作用外，AADI生物科学公司还在两项II期临床试验中评估FYARRO对于晚期或复发性子宫内膜样型子宫内膜癌（EEC）和神经内分泌肿瘤（NETs）的效果。尽管公司已暂停新患者的入组，但先前入组的患者仍在继续接受给药，预计研究将在未来几个月提供初步的疗效信号。

The ongoing development of FYARRO underscores the company's commitment to improving treatment options for challenging cancers and advancing therapeutic options in unmet medical needs..

FYARRO的持续开发凸显了该公司致力于改善难治性癌症的治疗选择，并推进未满足医疗需求的治疗方案。

Drug Name

药品名称

FYARRO (sirolimus protein-bound/ABI-009)

FYARRO（西罗莫司蛋白结合型/ABI-009）

Molecule type

分子类型

Small molecule complex with human albumin

小分子与人血白蛋白的复合物

Developer

开发者

Whitehawk Therapeutics (formerly Aadi Bioscience)

白鹰治疗公司（前身为Aadi生物科学公司）

Primary Indication

主要适应症

PEComa (approved); evaluating in TSC1 and TSC2 alterations and advanced or recurrent EEC and NETs

PEComa（已批准）；评估TSC1和TSC2改变以及晚期或复发性EEC和NETs

Mechanism of action

作用机制

mTOR inhibitor

mTOR抑制剂

Route of administration

给药途径

Intravenous

静脉注射

Learn more about FYARRO projected market size for PEComa @

了解更多关于FYARRO在PEComa的预计市场规模 @

FYARRO Market Potential

FYARRO市场潜力

Perivascular epithelioid cell neoplasms (PEComas) are rare tumors of the soft tissues, typically developing around small blood vessels in organs such as the lungs, gastrointestinal tract, kidneys, liver, and uterus. According to the WHO classification, PEComa not otherwise specified (NOS) encompasses both benign forms and more aggressive, malignant variants.

血管周上皮样细胞肿瘤（PEComas）是软组织中的罕见肿瘤，通常在肺、胃肠道、肾脏、肝脏和子宫等器官的小血管周围形成。根据世界卫生组织分类，未特别指明的PEComa（NOS）包括良性形式以及更具侵袭性的恶性变种。

One of the more serious presentations commonly encountered in clinical practice is abdominopelvic perivascular epithelioid cell sarcoma, often referred to as malignant PEComa. In 2023, the number of new PEComa cases in .

在临床实践中，较为严重的表现之一是腹盆腔血管周围上皮样细胞肉瘤，通常称为恶性PEComa。2023年，新发PEComa病例的数量为。

the United States

美国

was estimated at around 250, with projections indicating a gradual increase through 2034.

估计约为 250，预测表明到 2034 年将逐步增加。

Wide surgical resection remains the standard approach for localized PEComa, although there are no established guidelines for systemic therapy in such cases. While there has been a notable instance of an 80% tumor reduction with cytotoxic chemotherapy using doxorubicin and ifosfamide in a patient with extremity PEComa, most cases have shown limited benefit.

虽然目前对于局部PEComa的系统治疗尚无明确指南，但广泛的手术切除仍然是标准方法。尽管有报道称，在一例肢体PEComa患者中使用多柔比星和异环磷酰胺进行细胞毒性化疗后，肿瘤减少了80%，但大多数病例显示疗效有限。

Reports often document either disease progression during chemotherapy or residual tumor presence post-surgery. Limited data exist regarding the use of neoadjuvant radiation alone, but it may be approached similarly to other localized high-grade sarcomas. As with many other soft tissue sarcoma (STS) subtypes, the role of adjuvant chemotherapy remains uncertain.

报告通常记录化疗期间的疾病进展或术后残留肿瘤的存在。关于单独使用新辅助放疗的数据有限，但其应用方式可能与其他局部高级别肉瘤类似。与许多其他软组织肉瘤（STS）亚型一样，辅助化疗的作用仍不确定。

Most patients treated with adjuvant anthracycline-based regimens have experienced recurrence within a median follow-up of less than two years..

大多数接受基于蒽环类药物的辅助治疗方案的患者在中位随访时间不到两年内经历了复发。

Approximately 20% of patients are diagnosed with metastatic disease at presentation, and around 70% of those with initially localized malignant PEComa eventually develop metastases. Despite the disease's unpredictable progression, some patients—especially those with isolated or oligometastatic lesions or long disease-free intervals—may benefit from surgical removal of metastases, potentially achieving prolonged remission and control.

大约20%的患者在初诊时被诊断为转移性疾病，而约70%最初局部恶性的PEComa患者最终会发生转移。尽管该病的进展难以预测，但部分患者（尤其是那些孤立性或寡转移病灶，或具有长无病间隔期的患者）可能从转移灶的手术切除中获益，有望实现长期缓解和疾病控制。

Conventional STS chemotherapies have generally shown minimal activity in advanced PEComa, with agents such as anthracyclines, ifosfamide, paclitaxel, gemcitabine, and dacarbazine failing to produce significant responses..

传统的STS化疗在晚期PEComa中通常显示出较低的活性，蒽环类药物、异环磷酰胺、紫杉醇、吉西他滨和达卡巴嗪等药物未能产生显著反应。

Discover more about the PEComa market in detail @

详细了解PEComa市场更多信息@

PEComa Market Report

PEComa市场报告

Emerging Competitors of FYARRO

FYARRO的新兴竞争对手

Currently, there is no emerging drug in the pipeline targeting PEComa. However, the PEComa Market Dynamics might change in the coming years owing to quicker diagnosis and improved awareness of the disease. Pricing policies must also be considered to achieve great success in PEComa; this will further help launch an attractive product appropriate to the market..

目前，尚无在研药物针对PEComa。然而，由于诊断速度的提升和对疾病认识的提高，未来几年内PEComa市场动态可能会发生变化。要取得PEComa领域的巨大成功，还必须考虑定价策略；这将有助于推出一款符合市场需求的有吸引力的产品。

To know more about the number of competing drugs in development, visit @

要了解更多关于正在开发的竞争药物数量的信息，请访问 @

FYARRO Market Positioning Compared to Other Drugs

FYARRO市场定位与其他药物的比较

Key Milestones of FYARRO

FYARRO的关键里程碑

在

March 2025

2025年3月

, Aadi Bioscience

，Aadi Bioscience

announced that it had changed its name to Whitehawk Therapeutics.

宣布已将其名称更改为Whitehawk Therapeutics。

在

December 2024

2024年12月

, Aadi Bioscience

，Aadi Bioscience

announced that it had agreed to sell its commercial drug product FYARRO to KAKEN Pharmaceutical for

宣布已同意将其商业药物产品FYARRO出售给KAKEN制药公司，

USD 100 million

1亿美元

, an agreement to sell and issue

，一项出售和发行的协议

USD 100 million

1亿美元

of equity in a PIPE financing, and an exclusive license agreement for the development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics, a global Contract Research, Development and Manufacturing Organization, and Hangzhou DAC, a global leader in ADC innovation.

在与全球合同研究、开发和制造组织药明生物以及全球ADC创新领导者杭州DAC合作的PIPE融资中，获得了股权，并签订了独家许可协议，用于开发和全球商业化一个包含三个资产的临床前下一代抗体药物偶联物（ADC）组合。

And in .

而且在。

March 2025

2025年3月

, it was announced that the company's stockholders had approved the sale of FYARRO to KAKEN.

，公司股东已批准将FYARRO出售给KAKEN。

在

February 2022

2022年2月

, Aadi

，阿迪

launched FYARRO in the US for the treatment of advanced malignant PEComa. FYARRO is licensed to Aadi by Abraxis BioScience, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company (BMS).

在美国推出FYARRO，用于治疗晚期恶性PEComa。FYARRO由Abraxis BioScience授权给Aadi，该公司是Celgene Corporation的全资子公司，而Celgene Corporation是百时美施贵宝公司（BMS）的全资子公司。

Discover how FYARRO is shaping the PEComa treatment landscape @

发现FYARRO如何塑造PEComa治疗领域 @

FYARRO FDA Approval

FYARRO FDA批准

FYARRO Market Dynamics

FYARRO市场动态

Surgical resection

手术切除

remains the primary treatment approach for localized PEComas. In advanced or metastatic settings, conventional chemotherapy and tyrosine kinase inhibitors have delivered modest results. However,

仍然是局部PEComas的主要治疗方法。在晚期或转移性环境中，常规化疗和酪氨酸激酶抑制剂取得了有限的效果。然而，

mTOR inhibitors—especially FYARRO

mTOR抑制剂——尤其是FYARRO

—have emerged as a promising therapy. FYARRO, the only FDA-approved treatment for advanced malignant PEComas, utilizes

—已成为一种有前景的疗法。FYARRO是唯一获得FDA批准用于晚期恶性PEComas的治疗方案，利用

nanoparticle albumin-bound technology

纳米颗粒白蛋白结合技术

to deliver targeted action against tumors with elevated mTOR pathway activity, often linked to TSC1 or TSC2 mutations. In the pivotal

针对与TSC1或TSC2突变相关的肿瘤，提供靶向治疗以应对mTOR通路活性升高。在关键的

AMPECT trial,

AMPECT试验，

FYARRO demonstrated an overall response rate (ORR) of 39%, a median duration of response (mDOR) of 39.7 months, and a median overall survival of 53.1 months, earning its place as the preferred treatment in NCCN guidelines.

FYARRO 表现出 39% 的总缓解率 (ORR)、39.7 个月的中位缓解持续时间 (mDOR)，以及 53.1 个月的中位总生存期，成为 NCCN 指南中的首选治疗方案。

Although FYARRO is central to current treatment strategies, other mTOR inhibitors—such as

尽管FYARRO是当前治疗策略的核心，但其他mTOR抑制剂——例如

RAPAMUNE (sirolimus), AFINITOR (everolimus), and TORISEL (temsirolimus)

雷帕鸣（西罗莫司）、依维莫司（everolimus）和托瑞塞（替西罗莫司）

—have shown clinical benefit despite not being specifically approved for PEComa. For example, everolimus has achieved sustained disease control in cases of metastatic small bowel PEComa. Additionally, the VEGFR inhibitor

—尽管未被特别批准用于PEComa，但已显示出临床益处。例如，依维莫司在转移性小肠PEComa病例中实现了持续的疾病控制。此外，VEGFR抑制剂

VOTRIENT (pazopanib)

VOTRIENT（帕唑帕尼）

has been used

已被使用

off-label

超说明书用药

to reduce tumor vascularization, though its effectiveness is still under evaluation. Traditional sarcoma chemotherapies have generally shown

为了减少肿瘤血管生成，尽管其有效性仍在评估中。传统的肉瘤化疗通常显示出

limited benefit

有限的好处

in PEComa, underscoring FYARRO's unique role.

在PEComa中，突显了FYARRO的独特作用。

Nevertheless, several unmet needs persist, including the

然而，仍存在一些未满足的需求，包括

need to better understand mechanisms of resistance

需要更好地理解耐药机制

, to develop

，以发展

more durable treatment options

更耐用的治疗选项

for advanced disease, and to identify reliable prognostic biomarkers for tailoring therapy.

对于晚期疾病，并确定可靠的预后生物标志物以调整治疗方案。

Advancing research and expanding clinical trial efforts

推动研究进展并扩大临床试验工作

into innovative targeted therapies could be key to overcoming these challenges.

转化为创新的靶向疗法可能是克服这些挑战的关键。

Dive deeper to get more insight into FYARRO's strengths & weaknesses relative to competitors @

深入研究以更深入地了解FYARRO相对于竞争对手的优势和劣势 @

FYARRO Market Drug Report

FYARRO市场药物报告

Table of Contents

Report Introduction

报告介绍

FYARRO: Whitehawk Therapeutics

飞亚洛：白鹰治疗公司

2.1

Product Overview

产品概述

2.2

Other Development Activities

其他开发活动

2.3

Clinical Development

临床开发

2.4

Clinical Trials Information

临床试验信息

2.5

Safety and Efficacy

安全性与有效性

2.6

Product Profile

产品概况

2.7

Market Assessment

市场评估

2.7.1

The 7MM Analysis

7MM分析

2.7.1.1

Cost Assumptions and Rebate

成本假设与回扣

2.7.1.2

Pricing Trends

价格趋势

2.7.1.3

Analogue Assessment

模拟评估

2.7.1.4

Launch Year and Therapy Uptake

上市年份与治疗吸收

2.7.2

The United States Market Analysis

美国市场分析

2.7.3

EU4 and the United Kingdom Market Analysis

EU4 与英国市场分析

2.7.3.1

Germany

德国

2.7.3.2

France

法国

2.7.3.3

Italy

意大利

2.7.3.4

Spain

西班牙

2.7.3.5

英国

2.7.4

Japan Market Analysis

日本市场分析

2.8

Market Drivers

市场驱动因素

2.9

Market Barriers

市场壁垒

2.10

SWOT Analysis

SWOT分析

Key Cross of Marketed Competitors of FYARRO

FYARRO市场竞争对手的关键十字路口

Key Cross of Emerging Competitors of FYARRO

新兴竞争对手的FYARRO关键十字路口

Related Reports

相关报告

PEComa Market

PEComa市场

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PEcoma市场洞察、流行病学和市场预测——2034年

report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PEComa companies, including

报告提供了对该疾病的深入理解、历史和预测的流行病学数据，以及市场趋势、市场驱动因素、市场障碍和主要的PEComa公司，包括

Whitehawk Therapeutics,

白鹰治疗公司，

among others.

其中包括。

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PEComa 管线

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报告全面洞察了研发管线情况、管线药物概况（包括临床和非临床阶段产品），以及主要的PEComa公司，包括

Whitehawk Therapeutics,

白鹰治疗公司，

among others.

其中包括。

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report delivers an in-depth understanding of market trends, market drivers, market barriers, and key STS companies such as

报告深入分析了市场趋势、市场驱动因素、市场障碍以及关键的STS公司，如

Gem Pharmaceuticals, Lytix Biopharma, Incyte Corporation, Daiichi Sankyo, NantPharma, Iovance Biotherapeutics, Agenus, Eli Lilly and Company, Adaptimmune, Aadi, AVEO Pharmaceuticals, Amgen,

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among others.

其中。

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软组织肉瘤管线

Soft Tissue Sarcoma Pipeline Insight

软组织肉瘤研发管线洞察

– 2025

report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key STS companies, including

报告全面洞察了研发管线的格局、管线药物概况，包括临床和非临床阶段产品，以及关键的STS公司，包括

Advenchen Laboratories, Philogen, Gradalis, Epizyme, Chugai Pharma France, CytRx, Taiho Pharmaceuticals, KaryoPharm Therapeutics, Nanobiotix, Apexigen, Lytix Biopharma, Incyte Corporation, Iovance Biotherapeutics, Aadi Bioscience, Inc., AVEO Pharmaceuticals, Bayer, VasGene Therapeutics, Mirati Therapeutics, Novartis Pharmaceuticals, Incyte Corporation, Tracon Pharmaceuticals, Jiangsu Hengrui Medicine, Exelixis, Qbiotics, AstraZeneca, Loxo Oncology, ImmunityBio, Monopar Therapeutics, Chipscreen Biosciences, Ltd., Agenus, C4 Therapeutics, Inc., Noxopharm Limited, Moleculin Biotech, Inc., Sunshine Guojian Pharmaceutical (.

阿德文琴实验室、菲洛根、格拉达利斯、爱必兹、中外制药法国、赛特瑞克斯、大鹏制药、凯里奥制药、纳米生物技术、顶点基因、莱蒂克斯生物制药、因赛特公司、艾尔维斯生物治疗、阿迪生物科学公司、AVEO制药、拜耳、瓦斯吉恩治疗、米拉蒂治疗、诺华制药、因赛特公司、特拉康制药、江苏恒瑞医药、艾克西利斯、Qbiotics、阿斯利康、洛索肿瘤学、免疫生物、莫诺帕治疗、芯片屏幕生物科学有限公司、艾格努斯、C4治疗公司、诺克索制药有限公司、分子生物技术公司、阳光国健制药。

Shanghai

上海

) Co., Ltd., Tracon Pharmaceuticals Inc., Guangdong Xiangxue Precision Medical Technology Co., Ltd., Cornerstone Pharmaceuticals, Takara Bio Inc., Jazz Pharmaceuticals, Lyell Immunopharma, Telix Pharmaceuticals,

）有限公司，Tracon制药公司，广东香雪精准医疗技术有限公司，基石制药，宝生物工程株式会社，Jazz制药，Lyell免疫制药，Telix制药，

among others.

其中。

About DelveInsight

关于DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

德尔维洞察是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来支持制药公司以提升其业绩。通过我们的基于订阅的平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。

。

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SOURCE DelveInsight Business Research, LLP

来源：DelveInsight商业研究公司

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