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罗氏乳腺癌新药Kadcyla获欧盟批准

新药编辑:新特药 更新时间:2015-04-12

2013年11月21日讯 /tumor.net.cn/ --罗氏(Roche)11月20日宣布,抗体偶联药物Kadcyla(trastuzumab emtansine,T-DM1)获欧盟委员会(EC)批准,用于既往接受过赫赛汀(Herceptin,通用名:trastuzumab,曲妥珠单抗)及一种紫衫类药物(taxane)治疗的、不能手术切除的局部晚期或转移性HER2阳性乳腺癌患者的治疗。

Kadcyla的获批,是基于国际性III期EMILIA研究的临床数据,该试验在既往接受过赫赛汀(Herceptin,通用名:trastuzumab,曲妥珠单抗)和一种紫杉类药物(taxane)治疗的HER2阳性转移性乳腺癌患者中开展,将Kadcyla与标准疗法进行了对比。研究数据表明,与标准疗法相比,Kadcyla显着改善了总生存期(OS,30.9个月 vs 25.1个月)和无进展生存期(PFS,9.6个月 vs 6.4个月),同时更少的患者经历严重不良事件。

此前,Kadcyla已分别于今年2月和9月获FDA和日本劳动卫生福利部(MHLW)批准,用于不能手术或复发性HER2阳性乳腺癌的治疗。

Kadcyla是首个获批用于HER2阳性转移性乳腺癌治疗的抗体偶联药物(ADC)。

目前,转移性乳腺癌(mBC)还没有可治愈的药物,因此,治疗的目的是帮助患者尽可能地生存的更久。HER2阳性mBR的治疗包括靶向药物和化疗方案。一些与标准化疗相关的副作用,会显着影响患者的生活质量,有时甚至有必要换药或停药。(tumor.net.cn)

关于Kadcyla:

Kadcyla是一种HER2靶向性疗法,是一种由罗氏曲妥珠单抗与ImmunoGen公司DM1细胞毒制剂相偶联的药物,具有2种抗癌属性:曲妥珠单抗的HER2抑制和DM1的细胞毒性。曲妥珠单抗和DM1之间采用一种稳定的连接子(linkers)偶联,将DM1递送至HER2阳性乳腺癌细胞。罗氏拥有Kadcyla的全球开发和商业化权利。

目前,罗氏正在开展数个研究,评价Kadcyla用于潜在额外用途的潜力,包括用于HER2阳性转移性乳腺癌的一线治疗,用于早期HER2阳性乳腺癌、晚期HER2阳性胃癌的治疗。

英文原文:Roche's Kadcyla approved in the EU for advanced HER2-positive breast cancer

-More than 70,000 people in Europe each year are diagnosed with advanced breast cancer, of whom approximately one in five will have HER2-positive disease

-There is currently no cure for advanced breast cancer, and whilst in recent years the outlook has improved, further treatments are needed to help ensure people continue to have options when their disease gets worse

-In a clinical study people with HER2-positive advanced breast cancer who were treated with Kadcyla survived almost six months longer than those receiving the standard treatment of lapatinib and Xeloda

-Patients also experienced fewer of the severe side effects commonly associated with chemotherapy, as Kadcyla’s targeted mode of action works to deliver the treatment directly to cancer cells, limiting damage to healthy tissues

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Kadcyla (trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer.

Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab) and a taxane, separately or in combination. The indication also stipulates that those treated should either have received prior therapy for locally advanced or metastatic disease, or have had disease recurrence during or within six months of completing adjuvant therapy.

“Kadcyla's approval in the EU is important because this type of targeted medicine has been shown in clinical studies to offer clear benefits for people with advanced HER2-positive breast cancer,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Now that Kadcyla has been approved, we can begin discussions with the relevant EU reimbursement authorities to ensure that people who need this medicine can receive it as quickly as possible."

The decision is based on results from the pivotal Phase III EMILIA study in which people previously treated with Herceptin and a taxane for their HER2-positive advanced breast cancer were randomised to receive either Kadcyla or a standard treatment, lapatinib and Xeloda (capecitabine). People receiving Kadcyla survived significantly longer than those who received lapatanib and Xeloda (30.9 vs 25.1 months) and also lived for nearly 10 months (9.6 months) without their disease getting worse, a median of 3.2 months longer than those who received lapatinib and Xeloda. They also experienced fewer of the severe side effects commonly associated with chemotherapy, as Kadcyla’s targeted mode of action works to deliver the treatment directly to cancer cells, limiting damage to healthy tissues.

About Kadcyla

Kadcyla is the third targeted medicine Roche has developed for the treatment of HER2-positive breast cancer. It is a type of medicine called an antibody-drug conjugate and it connects two anti-cancer properties: the HER2 inhibition of trastuzumab (the active ingredient found in Herceptin) and the cytotoxic chemotherapy, DM1. The trastuzumab and the DM1 are joined together using a ‘stable’ linker to deliver DM1 directly to HER2-positive breast cancer cells.

Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About the EMILIA study

The EU filing of Kadcyla is based on results from EMILIA (TDM4370g/BO21977), an international, Phase III, randomised, open-label study comparing Kadcyla alone to the combination of lapatinib and Xeloda in 991 patients with HER2-positive locally advanced breast cancer or metastatic breast cancer who had previously been treated with Herceptin and a taxane chemotherapy.

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