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欧盟批准默克Erbitux用于更广泛结肠癌治疗

来源:生物谷 2013-12-25 07:01

2013年12月25日讯 /生物谷BIOON/ --默克(Merck KGaA)12月23日宣布,欧盟委员会(EC)已批准了抗癌药物爱必妥(Erbitux,通用名:cetuximab,西妥昔单抗)产品信息的II类变更,该变更将更新Erbitux用于转移性结直肠癌患者治疗的利益-风险(benefit-risk)评估。

基于Erbitux药品利益-风险属性中mCRC RAS肿瘤状态的总的数据,欧盟委员会批准Erbitux用于携带野生型RAS的转移性结直肠癌(mCRC)患者的治疗,该批准主要参考了OPUS研究中新的生物标志物数据。

在评估抗EGFR单克隆抗体(如Erbitux)相关研究的近期分析中,将携带KRAS野生型肿瘤状态(外显子2)的患者肿瘤样本,进行了更多的RAS突变(定义为KRAS外显子3或4突变,和/或NRAS外显子2,3或4突变)评估。这些研究的数据表明,携带RAS野生型肿瘤的患者可能能够从Erbitux治疗中受益,而携带RAS突变肿瘤的患者可能不能从Erbitux治疗中受益。

在更新的产品信息中,Erbitux将适用于联合伊立替康(irinotecan)为基础的化疗用于表达表皮生长因子受体(EGFR)的RAS野生型mCRC患者的治疗、联合Folfox用于一线治疗,或作为单药疗法用于奥沙利铂(oxaliplatin)和伊立替康化疗治疗失败的患者以及对伊立替康不耐受的患者。在这一标签变更中,Erbitux+含奥沙利铂化疗组合疗法将被限制至携带突变型RAS mCRC患者群体或RAS mCRC状态未知的患者群体。

关于OPUS研究:

OPUS是一项随机、对照II期研究,涉及337例mCRC患者,其中179例为携带KRAS野生型(外显子2)肿瘤,研究数据证明了Erbitux+Folfox-4(奥沙利铂为基础的化疗)联合疗法,相对于Folfox-4单药疗法的疗效。该项研究中,RAS肿瘤状态的分析数据,已提交至2014年胃肠道癌症研讨会(ASCO GI)会议。(生物谷Bioon.com)

英文原文:EU backs Merck's Erbitux for broader colon cancer treatment

-The European Commission’s approval is based on the CHMP positive opinion
-Label update comes in response to new biomarker data obtained from the OPUS study

Darmstadt, Germany, December 23, 2013 – Merck today announced that the European Commission has approved the Type II variation to amend the Erbitux® (cetuximab) product information, updating the indication for Erbitux to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC). The approval of the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) (issued in November 2013) and is based on the totality of data emerging on the role of mCRC RAS tumor status in the benefit–risk profile of the drug. The approval primarily refers to new biomarker data from the OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) study.(1)

In recent analyses of studies evaluating monoclonal anti-epidermal growth factor receptor (EGFR) antibodies, such as Erbitux, tumor samples of patients with KRAS wild-type tumor status (exon 2) were assessed for additional RAS mutations (defined as mutations in exons 3 or 4 of KRAS and/or exons 2, 3 or 4 of NRAS). The results from these studies suggest that patients with RAS wild-type tumors may benefit from treatment with Erbitux, while patients with RAS mutant tumors may not.
“We fully endorse the update to the indication of Erbitux in metastatic colorectal cancer, as it will provide further guidance to physicians who manage patients with colorectal cancer,” said Belén Garijo, President and CEO of Merck Serono. “We will now be working with the regulatory agencies to effectively communicate the implications of this label change to healthcare professionals and patients.”

In the updated product information, Erbitux will now be indicated for the treatment of patients with EGFR-expressing, RAS wild-type mCRC in combination with irinotecan-based chemotherapy, in first-line in combination with FOLFOX, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. In this label change, the existing contraindication for the combination of Erbitux with oxaliplatin-containing chemotherapy is now extended to include patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.

The full Erbitux patient information will be publicly available in the revised SmPC.

About the OPUS Study
OPUS is a randomized, controlled, Phase II trial, involving 337 mCRC patients, 179 with KRAS wild-type (exon 2) tumors, demonstrating the efficacy of Erbitux plus FOLFOX-4 (oxaliplatin-based therapy) versus FOLFOX-4 alone.2 Results of a RAS tumor status analysis will be presented at Gastrointestinal Cancers Symposium (ASCO GI) in January 2014 in San Francisco, California, U.S.

About Colorectal Cancer
Colorectal cancer (CRC) is the fourth most common cancer worldwide, with an estimated incidence of more than 1.2 million cases globally.3 An estimated 608,000 deaths from CRC occur worldwide each year, accounting for 8% of all cancer deaths and making it the fourth most common cause of death from cancer.3 Almost 60% of the cases occur in developed regions, and incidence and mortality rates are substantially higher in menthan in women.3 In Europe alone, an estimated 436,000 people develop CRC every year, with approximately 212,000 people dying from the disease annually.4

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