Sirtex Medical的SIR-Spheres® Y-90树脂微球获得FDA批准用于治疗不可切除的肝细胞癌-动脉网

Sirtex Medical's SIR-Spheres® Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma

CISION 等信源发布 2025-07-07 21:00



可切换为仅中文







Expanded indication makes

扩大适应症使

SIR-Spheres

the first and only radioembolization therapy in the U.S. approved to treat both unresectable hepatocellular carcinoma and metastatic colorectal cancer

美国首个也是唯一一个获批用于治疗不可切除的肝细胞癌和转移性结直肠癌的放射栓塞疗法

WOBURN, Mass.

马萨诸塞州伍伯恩

，

July 7, 2025

2025年7月7日

/PRNewswire/ --

Sirtex Medical ('Sirtex')

Sirtex医疗公司（'Sirtex'）

, a leading manufacturer of interventional oncology solutions, today announced that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres

，介入肿瘤学解决方案的领先制造商，今天宣布美国食品和药物管理局 (FDA) 批准了 SIR-Spheres。

Y-90

钇-90

resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in

用于治疗不可切除的肝细胞癌（HCC）的树脂微球

the United States

美国

. With this approval, SIR-Spheres

。随着这一批准，SIR-Spheres

is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S.

是美国唯一获批用于治疗肝脏转移性结直肠癌 (mCRC) 和肝细胞癌 (HCC) 的放射栓塞疗法。

HCC is the most common form of liver cancer in adults in the U.S., according to the

根据美国的数据，HCC是成人最常见的肝癌形式，

American Cancer Society

美国癌症协会

. Radioembolization–commonly referred to as selective internal radiation therapy (SIRT)–with SIR-Spheres

放射栓塞术——通常被称为选择性内部放射治疗（SIRT）——使用SIR-Spheres

uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC. This approval gives clinicians expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals.

使用个性化剂量测定法将最佳辐射剂量直接传递到肝细胞癌（HCC）患者的肿瘤。这一批准使临床医生在选择与患者特定需求和治疗目标相符的肝脏定向疗法时具有更大的灵活性。

'The expanded indication makes SIR-Spheres

“扩大适应症使SIR-Spheres

the only

唯一的

Y-90

钇-90

treatment approved in the U.S. for both HCC and mCRC,' said

在美国获批用于治疗肝细胞癌和转移性结直肠癌，”

Matt Schmidt

马特·施密特

, CEO of Sirtex. 'This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empowers physicians to treat patients when and where it works best.'

“这一里程碑反映了我们持续致力于提供灵活、个性化的治疗方案——每天都有多种剂量选项可用——使医生能够在最合适的时机和地点治疗患者。”

This regulatory milestone is supported by results from the DOORwaY

这一监管里程碑得到了DOORwaY结果的支持

study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres

研究，一项前瞻性、多中心、开放标签的临床试验，评估SIR-Spheres的安全性和有效性

in treating HCC. The study enrolled 100 patients across 18 U.S. centers, with 65 patients included in the interim primary efficacy cohort. DOORwaY

在治疗肝细胞癌（HCC）方面，该研究在美国18个中心招募了100名患者，其中65名患者被纳入中期主要疗效队列。DOORwaY

met its prespecified co-primary endpoints, demonstrating a best overall response rate (ORR) of 98.5% as assessed by independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response (DoR) exceeded 300 days.

达到了预先设定的共同主要终点，独立中心评估的最佳总体缓解率（ORR）为98.5%。所有可评估的患者均显示出缓解，表明局部肿瘤控制率达到100%。此外，缓解持续时间（DoR）的中位数超过300天。

These findings highlight SIR-Spheres.

这些发现突出了SIR-Spheres。

as a highly effective liver-directed therapy with a favorable safety profile.

作为一种高效的肝脏定向疗法，具有良好的安全性。

'This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,' said Dr.

“这项研究推动了放射栓塞领域的发展，提供了可重复的剂量学结果，并且具有与非常积极的临床结果相关联的强大安全性，”博士说。

Armeen Mahvash

马赫瓦什·阿尔米恩

, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY

，MD安德森癌症中心介入放射科医生，DOORwaY的联合首席研究员

Study. 'This will give multidisciplinary care teams the confidence to recommend SIR-Spheres

研究。‘这将使多学科护理团队有信心推荐SIR-Spheres微球’

for HCC treatment.'

肝癌治疗。'

For more information and details on how to incorporate SIR-Spheres

有关如何整合SIR-Spheres的更多信息和详细信息，请参阅

into your practice, please contact Sirtex at

纳入您的实践，请联系 Sirtex

info-use@sirtex.com

。

About SIR-Spheres

关于SIR-Spheres

SIR-Spheres

SIR-球体

Y-90

钇-90

resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine)..

树脂微球适用于无法切除的肝细胞癌（HCC）患者的局部肿瘤控制，这些患者无大血管侵犯、Child-Pugh A级肝硬化、肝功能代偿良好且身体状况良好。它们也适用于原发性结直肠癌不可切除的肝转移瘤的治疗，并作为氟尿苷（FUDR）辅助肝动脉化疗（IHAC）的一部分。

Caution: Federal (

注意：联邦（

USA

美国

) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use (

法律限制此设备仅可通过医生或根据医生的指示进行销售。请参阅使用说明书。

www.sirtex.com/sir-spheres/risks_adverse-events

www.sirtex.com/sir-spheres/风险_不良事件

) for a complete listing of indications, contraindications, side effects, warnings and precautions.

）有关适应症、禁忌症、副作用、警告和预防措施的完整列表。

About Sirtex

关于Sirtex

Sirtex Medical is a global healthcare company focused on advancing minimally invasive, liver-directed cancer and embolization therapies. With offices in the U.S.,

Sirtex Medical 是一家全球性医疗保健公司，专注于推进微创、针对肝脏的癌症和栓塞疗法。该公司在美国设有办事处，

Australia

澳大利亚

，

Europe

欧洲

, and

，以及

Asia

亚洲

, Sirtex delivers innovative interventional oncology and embolization solutions to physicians and patients worldwide. The company's lead product, SIR-Spheres

，Sirtex 向全球的医生和患者提供创新的介入肿瘤学和栓塞解决方案。该公司的主要产品是 SIR-Spheres。

Y-90

钇-90

resin microspheres, is now the only FDA approved product in

树脂微球，现在是唯一获得FDA批准的产品在

the United States

美国

indicated for both the treatment of hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC). For more information, visit

适用于肝细胞癌（HCC）和转移性结直肠癌（mCRC）的治疗。欲了解更多信息，请访问

www.sirtex.com

。

APM-US-010-06-25