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CHMP建议批准默克爱必妥(Erbitux)用于野生型RAS mCRC治疗

来源:生物谷 2013-11-26 08:48

2013年11月25日讯 /生物谷BIOON/ --默克(Merck KGaA)11月22日宣布,欧洲药品管理局(EMA)人用医药产品委员会(CHMP)已就爱必妥(Erbitux,通用名:cetuximab,西妥昔单抗)产品信息的变更发布了积极意见,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,CHMP建议批准Erbitux用于携带野生型RAS的转移性结直肠癌(mCRC)患者的治疗,该积极建议主要参考了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。

基于CHMP的建议,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。(生物谷Bioon.com)

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。

英文原文:Merck announces CHMP Positive Opinion to Update Erbitux Metastatic Colorectal Cancer Labeling to Patients with RAS Wild-type Tumors

CHMP (Committee for Medicinal Products for Human Use) recommendation comes in response to new biomarker data obtained from the OPUS study

Darmstadt, Germany, November 22, 2013 – Merck today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on a variation to the Erbitux? (cetuximab) product information, updating the assessment of benefit-risk in patients with metastatic colorectal cancer (mCRC). The CHMP has recommended the approval of the indication for Erbitux in the treatment of patients with RAS wild-type mCRC, based on the totality of data emerging on the role of mCRC RAS tumor status in the benefit-risk profile of the drug. The recommendation primarily refers to new biomarker data from the OPUS study(1).

In recent analyses of studies evaluating monoclonal anti-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 indicate that patients with RAS wild-type tumors may benefit from treatment with Erbitux, while patients with RAS mutant tumors may not.
“We are pleased with this important evolution of the label for Erbitux based upon new emerging data from our previous and ongoing studies of patients living with colorectal cancer,” said Dr. Annalisa Jenkins, Head of Global Research and Development at Merck Serono. “As the molecular basis and understanding of disease evolves we are committed to embracing the principles of patient-centric drug development and personalized medicine.”

Based on the CHMP’s recommendation and pending agreement of the European Commission, Erbitux will be indicated for the treatment of patients with epidermal growth factor receptor-expressing, RAS wild-type mCRC in combination with irinotecan-based chemotherapy, in 1st 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 combination of Erbitux with oxaliplatin-containing chemotherapy would be contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.

About the OPUS Study
OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) 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 have been submitted for presentation at Gastrointestinal Cancers Symposium (ASCO GI) 2014.

About Colorectal Cancer
Colorectal cancer (CRC) is the fourth most common cancer worldwide, with an estimated incidence of more than 1.2 million cases globally3. 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 cancer3. Almost 60% of the cases occur in developed regions, and incidence and mortality rates are substantially higher in menthan in women3. In Europe alone, an estimated 436,000 people develop CRC every year, with approximately 212,000 people dying from the disease annually4

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