文章来源：生物谷
2014年12月3日讯 /生物谷BIOON/ --阿斯利康（AstraZeneca）近日宣布，FDA已接受审查肿瘤学药物易瑞沙（Iressa，通用名：gefitinib，吉非替尼）新药申请（NDA），作为一种靶向性单药疗法，用于经一款伴随诊断试剂盒证实为晚期或转移性表皮生长因子受体突变阳性（EGFRm）非小细胞肺癌（NSCLC）患者的治疗。FDA已指定Iressa NDA处方药用户收费法（PDUFA）目标日期为2015年第三季度。
Iressa NDA的提交，是基于IV期IFUM（易瑞沙后续评估）研究的数据，该研究提供了Iressa治疗白人（Caucasian）患者的疗效证据。同时，该药NDA也得到了III期IPASS研究及其他协作研究结果的支持。
Iressa是一种表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），能够阻断导致肿瘤生长和扩散的信号通路。EGFR是一种在许多类型肿瘤细胞上呈异常高水平表达的蛋白，尤其是非小细胞肺癌（NSLCL）。在欧盟，Iressa是EGFR突变阳性NSCLC的标准治疗药物，适用于伴有EGFR酪氨酸激酶激活型突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。因此，只有肿瘤EGFR突变阳性的患者群体适合Iressa治疗。
Iressa（易瑞沙）于2002年上市，目前已获全球90多个国家批准。在美国，阿斯利康正与德国Qiagen（凯杰）合作开发循环肿瘤DNA(ctDNA)伴随诊断试剂盒（相关新闻：阿斯利康与QIAGEN合作开发易瑞沙（Iressa）伴随诊断试剂盒），指导Iressa用于晚期非小细胞肺癌（NSCLC）的治疗。
在欧洲，该款Iressa ctDNA伴随诊断试剂盒已获欧盟批准，使Iressa成为欧盟首个允许使用血液ctDNA评估肿瘤EGFR突变状态的EGFR酪氨酸激酶抑制剂。该试剂盒的上市，极大地改善了临床非小细胞肺癌（NSCLC）患者EGFR突变状态的诊断和治疗。
Iressa（易瑞沙）ctDNA伴随诊断试剂盒，是一种非侵入性诊断方法，利用一种高度敏感的技术，检测患者血液中循环肿瘤DNA（ctDNA）片段中的EGFR突变状态，从而区分出适合Iressa治疗的患者群体。在IV期IFUM研究中，该款ctDNA伴随诊断试剂盒表现出了强大且可靠的EGFR突变状态鉴别能力。（生物谷Bioon.com）
英文原文：New Drug Application for IRESSA accepted by US Food and Drug Administration
Tuesday, 2 December 2014
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA? (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), as identified through a companion diagnostic test. The Prescription Drug User Fee Act goal date for IRESSA will be in the third quarter 2015.
IRESSA is an EGFR tyrosine kinase inhibitor that acts by blocking the transmission of signals involved in the growth and spread of tumours. AstraZeneca’s NDA submission for IRESSA was based on data from the Phase III IFUM1 (IRESSA Follow-Up Measure) clinical trial, providing evidence of IRESSA’s efficacy in Caucasian patients. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study) clinical trial, as well as other collaborative group studies.
IRESSA is already approved in 90 countries for the treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase.
About IRESSA
IRESSA is a targeted monotherapy for the treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. EGFR mutations occur in approximately 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia.
IRESSA was launched in 2002 and is now approved in 90 countries worldwide.
In the US, AstraZeneca is working with Qiagen to develop a companion diagnostic test to guide the use of IRESSA in the treatment of patients with advanced NSCLC.
In Europe, the collaboration between AstraZeneca and Qiagen has resulted in IRESSA becoming the first EGFR tyrosine kinase inhibitor to have a European label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.