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加拿大批准Abraxane用于转移性胰腺癌的一线治疗

来源:生物谷 2014-08-08 09:49

2014年8月8日讯 /生物谷BIOON/ --美国生物制药公司新基(Celgene)8月6日宣布,加拿大卫生部批准Abraxane(注射用紫杉醇[白蛋白结合型])联合吉西他滨(gemcitabine),用于转移性胰腺癌成人患者的一线治疗。这是近20年来,加拿大批准的首个治疗转移性胰腺癌的药物。目前,Abraxane+吉西他滨联合疗法已获30多个国家批准,用于转移性胰腺癌的治疗,包括美国和欧盟。

迄今为止,吉西他滨作为胰腺癌的标准护理,已有超过15年的时间。而Abraxane+吉西他滨联合疗法,在临床试验中,已被证明对关键疗效终点表现出临床意义的显着改善,包括总生存期,同时具有良好的安全性,该联合疗法将为胰腺癌患者提供一个重要的新治疗选择,并为今后的临床研究奠定基础。

Abraxane的获批,是基于III期MPACT研究的数据。MPACT是一项开放标签、随机、国际性III期研究,研究中861例初治转移性胰腺癌患者随机接受ABRAXANE+吉西他滨联合疗法或吉西他滨单药疗法,研究数据表明,与吉西他滨单药疗法相比,ABRAXANE+吉西他滨联合疗法在总生存期(OS)、疾病无进展生存期(PFS)、整体响应率(ORR)上均表现出统计学意义的显着改善:OS(8.5个月 vs 6.7个月,HR=0.72,p<0.0001),死亡风险降低28%;PFS(5.5个月 vs 3.7个月,HR=0.69,p<0.0001),疾病进展或死亡风险降低31%;ORR(23% vs 7%,p<0.0001)。

在过去的20年中,在晚期胰腺癌患者中开展了超过30项随机III期临床试验,MPACT研究是表现出总生存期(OS)利益的4项研究之一。

关于胰腺癌:

胰腺癌是全球第8大癌症死因。胰腺主要由2种细胞类型组成:外分泌和内分泌。外分泌肿瘤是目前最常见的一种胰腺癌,恶性腺瘤占胰腺癌症的95%。在加拿大,对于各阶段的胰腺癌患者群体,5年存活率约为8%;而对于转移性胰腺癌而言,5年存活率约为2%。

关于Abraxane:

Abraxane是紫杉醇的白蛋白结合形式,采用nab专利技术生产。Abraxane的配方中含有白蛋白,白蛋白是一种人源性蛋白质,Abraxane的配方中不含溶剂。

Abraxane于2005年1月在美国首先获准用于治疗联合化疗无效的转移性乳腺癌或辅助化疗6个月内复发的乳腺癌 。既往治疗必须包含一种蒽环类,除非有临床禁忌症。Abraxane还在下列地区获准用于治疗转移性乳腺癌:加拿大、印度、欧盟/欧洲经济区(EU/EEA)、韩国、中国、澳大利亚、不丹、阿联酋、尼泊尔、新西兰、日本、俄罗斯、斯里兰卡和阿根廷。

2012年10月,美国FDA批准Abraxane联合卡铂用于不适合治愈性手术或放疗的局部晚期或转移性非小细胞肺癌的一线治疗。此外,Abraxane也获日本和阿根廷获准用于非小细胞肺癌的治疗,并且还在日本获准用于胃癌的治疗。

Abraxane目前处于不同的研究阶段,用于下列癌症的潜在治疗:黑色素瘤、膀胱癌、卵巢癌以及乳腺癌、肺癌的扩展应用。(生物谷Bioon.com)

英文原文:Health Canada Approves ABRAXANE® Plus Gemcitabine for First-Line Treatment of Patients with Metastatic Pancreatic Cancer

High unmet need addressed with first new approved treatment in eighteen years

MISSISSAUGA, ON, August 6, 2014 /CNW/ - Health Canada has approved PrABRAXANE® for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound [nab®] paclitaxel) for first-line treatment of adult patients with metastatic pancreatic cancer. The approval is welcome news for Canadians who are diagnosed with metastatic pancreatic cancer, and represents the first approved treatment for this disease in nearly two decades.

The Health Canada approval was based on the results of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study which was published in the New England Journal of Medicine in October 2013.  The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer from 11 countries, including Canada, and showed a statistically significant improvement in median overall survival with ABRAXANE plus gemcitabine compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P1

"This is a cancer where there are few effective treatments and the first-line approval of ABRAXANE in combination with gemcitabine represents an important advance," said. Dr. Malcolm J. Moore, Program Head, Medical Oncology and Hematology and Director, McCain Centre for Pancreatic Cancer at the Princess Margaret Cancer Centre, University Health Network in Toronto and an investigator in the MPACT trial. "This approval will certainly have an impact on the way physicians manage this disease in the future.  Pancreatic cancer is a tough one to deal with; patients are desperate and physicians are on the lookout for new advances. The addition of ABRAXANE to gemcitabine has demonstrated significant benefits in overall survival and this gives our patients hope."

"It's been quite some time since we've seen any type of treatment advance for pancreatic cancer making this news so important for patients.  This will give patients the hope that is needed to continue to fight," said Laurie Ellies, Co-founder, and Acting Executive Director of Pancreatic Cancer Canada.  "Over the past decade, there has been a significant improvement in cancer survival rates. Sadly, the same cannot be said about pancreatic cancer.  We're dealing with a deadly disease. For a person diagnosed with metastatic disease it can be a question of weeks. This year alone, we can expect an estimated 4,700 Canadians will be diagnosed with this disease.  If anything, this number tells us that we are desperately in need of more research and treatments - patients are counting on it."

ABRAXANE is commercially available in Canada.

About Pancreatic Cancer
Pancreatic cancer is the fourth-leading cause of cancer-related death in Canada.2 The pancreas is composed of two main cell types: exocrine and endocrine. Adenocarcinoma is a sub-type of exocrine tumors and accounts for about 95% of cancers of the pancreas.3 For all stages of pancreatic cancer combined, the five-year survival rate in Canada is about 8%. For metastatic pancreatic cancer, the five-year survival is approximately 2% in Canada.2

About ABRAXANE®
ABRAXANE® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology.  ABRAXANE is formulated with albumin, a human protein, and is free of solvents. The most common adverse reactions (≥ 20%) with a ≥ 5% higher incidence in the ABRAXANE/gemcitabine treatment group are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration.4

Please refer to the ABRAXANE product monograph for complete safety information.

ABRAXANE in combination with gemcitabine for the treatment of metastatic pancreatic cancer is approved in the United States and 30 other countries, including Argentina and Australia as well as countries in Europe.

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